21 Clinical Management jobs in India

**JOIN AMGEN'S MISSION OF SERVING PATIENTS**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Associate Vice President, Clinical Data Management**
**Live**
**What you will do**
Let's do this. Let's change the world. The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.
**The AVP will lead Amgen's Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.**
This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.
The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.
**Responsibilities:**
+ **Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.**
+ **Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.**
+ **Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.**
+ Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
+ Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
+ **Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.**
+ Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
+ Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
+ Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
+ Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
+ Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
+ Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
+ Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
+ Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
+ Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
**Basic Qualifications:**
+ **Bachelor's or master's degree with 25+ years of data management experience AND**
+ **10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources**
**Preferred Qualifications:**
+ Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
+ **Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).**
+ Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen's global clinical development efforts.
+ Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
+ **Understanding of clinical data standards (CDISC, SDTM, ADaM).**
+ **Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions**
+ Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
+ Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
+ **Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).**
+ **Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).**
+ Familiarity with decentralized trial models and digital health technologies.
They will also embody the Amgen leadership attributes which are:
+ **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
+ **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection
+ **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
+ **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**_OBJECTIVES/PURPOSE_**
+ Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP).
+ In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM):
+ Responsible for oversight of the execution of studies in the assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
+ Oversight of strategic CRO partners and/or other vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives.
+ Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic, inputs including study feasibility, budget, and timeline for assigned clinical programs
**_ACCOUNTABILITIES_**
+ Accountable for developing regional operational strategy for assigned clinical studies.
+ Contribute to the translation of CDP into an optimal operational strategy and plan. Lead assessment of various scenarios operational for optimal execution of CDP.
+ Collaborate with key investigators to reflect feasible and realistic operational inputs to CDP and ensure timeline and quality of studies meet the needs of CDP.
+ Provide subject matter expertise and operational input into protocol synopsis and protocol, obtaining opinions in terms of study execution from key investigators, as appropriate.
+ Challenge study team to ensure that operational feasibility, inclusive of patient and site burden and that timelines meet the needs of CDP.
+ Validate budget and ensure impacts are adequately addressed.
+ Participate in site selection process, with a focus on providing country insights, and therapeutic expertise to ensure alignment between study execution plan and program strategy.
+ Responsible for clinical study budget planning and management, and accountable for external spending related to clinical study execution. Works closely with relevant stakeholders (strategic CRO partners, other vendors, CSM, COPL, and Program Management, Outsourcing, and Finance) to ensure the accuracy of budget spending on a regular basis.
+ Oversee strategic CRO partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight includes but is not limited to:
+ Review and approval of key risk-based monitoring documents/plans, periodic review of outputs, decisions, and actions related to risk-based monitoring.
+ Documented review and monitoring of issues, risks and, decisions at the study level.
+ Support the identification of trends across sites and/or the study.
+ Review and provide clinical operations expertise into clinical documents related to the drug development process:
+ Creation and maintenance of clinical trial materials, such as Investigator Brochures, study synopsis & protocols, clinical study reports, etc.
+ Preparation of key regulatory meetings, as appropriate.
+ Collaborate with cross-functional counterparts and strategic CRO partners/other vendors to ensure inspection readiness and lead Clinical Operations aspects of inspection readiness activities and act as subject matter expert during regulatory inspections.
+ Actively seek new ways of working more efficiently to meet the needs of clinical development, such as cost-reduction, time-savings, efficiency, and quality.
+ Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
+ Responsible for talent development, including training and mentoring less experienced staff.
+ Seek an efficient way to maximize operational excellence in the cross-regional collaboration (e.g. Japan & Asia) with innovative ideas.
**_CORE ELEMENTS RELATED TO THIS ROLE_**
**Program**
+ Provide operational expertise and strategic inputs to the development of CDP and lead assessment of various operational scenarios for optimal execution of CDP.
+ Recognized as a clinical operations expert by other functions and stakeholders across R&D.
**Organization**
+ Actively seek new ways of executing studies more efficiently to meet the needs of clinical development and encourage the function.
**Capability development**
+ In addition to the self-development, think about supporting the development of Clinical Operations staff by sharing knowledge and experience with them.
**_DIMENSIONS AND ASPECTS_**
**Technical/Functional (Line) Expertise**
+ Have sufficient knowledge of regulatory and compliance requirements and guidance for clinical development, assigned Therapeutic Areas (TAs), project governances, and working models and accurately assess the impact of these on the assigned TA and programs.
**Leadership**
+ Demonstrate ability to work across functions, regions, and cultures.
+ Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
+ Train and develop less experienced staff with an awareness of mid- to long-term function goals and clinical development.
**Interaction**
+ Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
+ Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
**Innovation**
+ Recommend and influence the ideal model and approach for meeting the program goals and TA operational strategies.
+ Challenge status quo and bring forward innovative solutions.
**Complexity**
+ Work in global ecosystem (internal and external) with a high degree of complexity.
**Decision-making and Autonomy**
+ Provide input and implement appropriate strategies with understanding the goals of the function and assigned TA.
**_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
+ Bachelor's Degree or international equivalent required, Life Sciences preferred.
+ Innovate and challenge peers and teams to think and work differently; Work independently, excel at solving issues without the need for support, but is effective at enlisting support for specific asks when necessary.
+ Participate and lead clinical operations in cross-functional initiatives and workstreams that affect clinical operations; Adapt ways of working to the function's current state and formulate strategic plans to work within the existing framework.
+ Capable of assessing gaps cross-functionally and can take a supportive role in leading changes that benefits the function as it related to clinical trial execution and study management.
+ Encourage and provide input, suggestions, and support for competency building within the organization.
+ Demonstrated excellence in study management, including scenario assessment, risk assessment and contingency planning.
+ Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills.
+ Talent development skills to enhance capabilities.
+ Experience of 10+ years in pharmaceutical industry and/or clinical research organization, including 7+ years of clinical study management/oversight.
+ Experience must include Phase 1, 2, 3 studies and global/international studies or programs.
+ Experience in more than one therapeutic area.
+ English (fluently in oral and written communication)
+ Local language (fluently, a native level)
**TRAVEL REQUIREMENTS:**
+ Requires approximately 5-20 % travel, including overnight and local/international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time

·    Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks

·    Triage of Safety cases

·    Oversight of data discrepancy management

·    Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF

·    Responsible for compiling HoS content

·    Conduct the protocol amendment impact assessment and complete appropriate documentation

·    Manage migration and audit trail reports

·    Create slides for study-specific EDC investigator training

·    Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.

·    Provide study specific training to data manager (DM)

·    Contribute to the Data Management Plan (DMP)

·    Request DTS creation and ensure DTS finalized and complete for any LSH loads

·    Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)

·    Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)

·    Manage global and study-specific data entry conventions

·    Facilitate versioning, including Unlock/audit trail review & Archival process

·    Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design

·    Timely communication with key stakeholders on issues and risks, including

o   Brings CDR, DWA, and SD together to discuss post-production changes when identified

·    Provide critical information to PL who will communicate with study team

·    Log any action issues into DS Hub and resolve outstanding issues assigned to DA

·    Mange assigned activities to meet milestone dates

·    Ask questions to get information needed to meet end goals

·    Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)

What you need

·    A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree

·    Minimum 2 years to 6 years of experience in clinical data management

·    Proactively communicate ownership of studies

·    Critical thinking to identify root causes and best solutions for data discrepancy management

·    Confidence to have tough conversations and make challenging decisions

·    Enables an environment of open and honest communication and critical thinking within DSS study team

·    Influence internal team to meet timelines by holding stakeholders accountable

·    Ability to work with different personalities to get the work done

·    Willingness to seek out information to accomplish goal

·    Proactive communication

Key Responsibilities

1. Data Analysis & Insights

• Gather, validate, and analyze data from clinical, operational, and administrative systems.
• Build interactive reports and dashboards using Power BI , Tableau , or similar tools to present insights to leadership and stakeholders.
• Generate both routine and ad hoc analytical outputs to support business decisions and performance reviews.

2. Performance Measurement

• Develop and monitor Key Performance Indicators (KPIs) and operational metrics across clinical and research programs.
• Identify performance trends, highlight deviations, and provide actionable insights to improve efficiency and quality.
• Present data-driven findings in a clear, visual, and strategic format for leadership teams.

3. Clinical Operations & Research Support

• Support clinical operations and clinical research teams by analyzing data related to study execution, site performance, patient enrollment, and protocol adherence.
• Provide analytical inputs for resource planning, process optimization, and cost analysis.
• Collaborate with research and operations teams to improve data governance and consistency across systems.

4. Process & Quality Improvement

• Partner with cross-functional teams to evaluate workflows, identify bottlenecks, and recommend process improvements.
• Leverage data analytics to drive initiatives that improve operational efficiency , study performance , and patient outcomes .
• Contribute to continuous improvement efforts through evidence-based analysis and metric tracking.

Qualifications & Skills

• Bachelor’s or Master’s degree in Life Sciences, Healthcare, Statistics, Data Analytics , or related discipline.
• 4–6 years of experience in data analytics within clinical operations , clinical research , or healthcare domains .
• Strong proficiency in:
• Data visualization tools: Power BI, Tableau, or Qlik
• Querying languages: SQL (Python or R a plus)
• Data handling: Advanced Excel, data cleaning, and transformation techniques
• Solid understanding of clinical operations processes , KPIs, and research data frameworks.
• Excellent analytical, problem-solving, and storytelling skills with a strong attention to detail.
• Effective communicator who can translate data insights into business actions.
• Ability to work independently with minimal supervision while collaborating across diverse teams.
• Deep functional/domain Expertise/experience with CTMS (not EDC)

About Agilisium

Agilisium is the Life Sciences industry’s premier Autonomous Agentic AI and Applied AI Services Company . We reimagine, develop, and co-develop AI-engineered business processes that are autonomous, scalable, and purpose-built for Life Sciences.

Over the past decade, we’ve established deep credibility across global pharma and biotech organizations through our specialized expertise and consistent growth:

• Everest Group – Recognized as a Leader in Life Sciences Digital Services for the Mid-Market
• Inc. 5000 – Featured among the fastest-growing companies in the U.S. for 9 consecutive years
• AWS Advanced Consulting Partner – one of the Top 13 companies globally to hold both GenAI and Life Sciences Competency Badges
• Trusted by Fortune 500 Pharma – Partnering with several Top 10 global Life Sciences companies

Agilisium continues to invest in top-tier talent to fuel innovation, scalability, and impact across the Life Sciences value chain.

Learn more:

Our client is a leading organization dedicated to community and social care, seeking a dedicated and experienced Clinical Operations Manager to oversee the smooth functioning of its services in **Visakhapatnam, Andhra Pradesh, IN**. This vital role requires a compassionate leader with a strong understanding of healthcare operations, patient care, and regulatory compliance. You will be responsible for managing the day-to-day operations of clinical services, ensuring the highest standards of patient care are maintained. This includes overseeing staff scheduling, resource allocation, quality assurance, and adherence to all relevant healthcare regulations and protocols. The ideal candidate will have a background in nursing, allied health, or healthcare administration, with demonstrable experience in managing clinical teams and facilities. You will play a key role in fostering a positive and supportive work environment for clinical staff, promoting professional development, and ensuring effective communication across all levels. Responsibilities also include managing budgets, optimizing operational efficiency, and collaborating with other departments and external stakeholders to enhance service delivery. A proactive approach to problem-solving, strong leadership qualities, and a commitment to patient well-being are essential. This is an opportunity to make a significant contribution to the health and welfare of the community.
Responsibilities:

• Manage and coordinate all daily clinical operations to ensure efficient and effective service delivery.
• Supervise, mentor, and evaluate clinical staff, fostering a culture of excellence and collaboration.
• Develop and implement operational policies and procedures to ensure compliance with healthcare regulations and standards.
• Oversee patient scheduling, resource management, and inventory control.
• Monitor quality of care, implement improvement initiatives, and ensure patient satisfaction.
• Manage departmental budgets, control costs, and optimize resource utilization.
• Liaise with medical professionals, administrative staff, and external partners to ensure seamless coordination of care.
• Ensure the maintenance of accurate and confidential patient records.
• Participate in strategic planning and contribute to the development of new services.
• Handle patient complaints and resolve operational issues promptly.

Qualifications:

• Bachelor's degree in Nursing, Allied Health Sciences, Healthcare Administration, or a related field. Master's degree preferred.
• Minimum of 5 years of experience in clinical operations management or a similar leadership role within a healthcare setting.
• Strong knowledge of healthcare regulations, patient care standards, and operational best practices.
• Proven leadership and team management skills.
• Excellent organizational, problem-solving, and decision-making abilities.
• Proficiency in healthcare management software and EMR/EHR systems.
• Strong communication and interpersonal skills.
• Ability to manage budgets and financial resources effectively.
• Commitment to providing high-quality patient care.

Our client is seeking a dedicated and compassionate Clinical Operations Specialist to join their team in Visakhapatnam. This role is integral to ensuring the seamless delivery of high-quality community and social care services. You will be responsible for coordinating patient care, managing administrative tasks, and supporting the clinical team to achieve optimal patient outcomes. The ideal candidate will possess strong organizational skills, a deep understanding of healthcare protocols, and a commitment to patient well-being.

Responsibilities:

• Coordinate and manage patient care schedules and appointments.
• Liaise between patients, families, and healthcare providers to ensure clear communication.
• Maintain accurate and confidential patient records and documentation.
• Assist in the development and implementation of care plans.
• Monitor patient progress and report any changes or concerns to the clinical team.
• Manage inventory of medical supplies and equipment.
• Ensure compliance with all regulatory requirements and ethical standards.
• Provide administrative support to the clinical staff, including preparing reports and presentations.
• Facilitate communication and collaboration among multidisciplinary care teams.
• Organize and coordinate community outreach programs and health education initiatives.
• Handle patient inquiries and provide information regarding services and appointments.
• Assist with the onboarding and training of new clinical staff.
• Implement and refine operational workflows to enhance service delivery.
• Participate in quality improvement initiatives.
• Ensure a safe and therapeutic environment for all patients.

Qualifications:

• Bachelor's degree in Nursing, Healthcare Administration, Social Work, or a related field.
• Minimum of 3 years of experience in a clinical setting or healthcare administration.
• Strong knowledge of healthcare systems, patient care protocols, and medical terminology.
• Excellent organizational, time management, and multitasking abilities.
• Proficiency in EMR/EHR systems and standard office software.
• Exceptional interpersonal and communication skills, with the ability to empathize with patients.
• Ability to work independently and as part of a team.
• Understanding of community and social care principles.
• Commitment to patient confidentiality and data privacy.
• Experience in coordinating health programs is a plus.

This is a critical role contributing to the vital services provided by our client in Visakhapatnam, Andhra Pradesh, IN . This position requires a hands-on approach and a dedication to serving the community.

Our client is seeking a dedicated and experienced Clinical Operations Manager to oversee the day-to-day operations of their healthcare facility in **Thane, Maharashtra, IN**. This critical role involves managing a team of healthcare professionals, ensuring the delivery of high-quality patient care, and optimizing operational efficiency. You will be responsible for developing and implementing clinical protocols, managing budgets, and ensuring compliance with all regulatory requirements and healthcare standards. The ideal candidate will possess strong leadership, organizational, and problem-solving skills, with a deep understanding of healthcare management principles. You will work closely with physicians, nurses, and administrative staff to foster a collaborative and patient-centered environment. Key responsibilities include staff scheduling, performance management, resource allocation, and inventory control of medical supplies. Experience in quality improvement initiatives and patient safety programs is highly valued. You will also play a key role in strategic planning and operational development to enhance service delivery and patient outcomes. This position requires excellent communication and interpersonal skills to effectively liaise with patients, families, and external stakeholders. A thorough understanding of healthcare regulations, such as HIPAA and local health guidelines, is essential. The Clinical Operations Manager will lead efforts to improve patient satisfaction scores and streamline clinical workflows. You will be responsible for identifying areas for process improvement and implementing effective solutions. This role involves overseeing departmental budgets, ensuring financial targets are met while maintaining optimal service levels. The successful candidate will have a passion for healthcare excellence and a proven ability to lead and inspire teams in a demanding clinical setting. You will also be involved in the recruitment and onboarding of new clinical staff. Ensuring a safe and efficient working environment for all staff and patients is a top priority. This is an excellent opportunity for a seasoned healthcare professional to take on a leadership role within a reputable organization.

Responsibilities:

• Manage and supervise all clinical and administrative staff within the facility.
• Ensure the delivery of high-quality, patient-centered care.
• Develop, implement, and enforce clinical policies and procedures.
• Oversee departmental budgets and manage financial resources effectively.
• Ensure compliance with all healthcare regulations, licensing, and accreditation standards.
• Manage staff scheduling, performance, and professional development.
• Monitor patient satisfaction and implement strategies for improvement.
• Optimize clinical workflows and operational efficiency.
• Maintain adequate inventory of medical supplies and equipment.
• Collaborate with physicians and other healthcare providers to ensure coordinated patient care.

Qualifications:

• Bachelor's degree in Nursing, Healthcare Administration, Business Administration, or a related field. A Master's degree is preferred.
• Minimum of 5 years of experience in healthcare management or a related leadership role.
• Proven experience in clinical operations, patient care delivery, and staff management.
• Strong knowledge of healthcare regulations, accreditation standards, and best practices.
• Excellent leadership, communication, and interpersonal skills.
• Proficiency in healthcare management software and EMR/EHR systems.
• Demonstrated ability in budget management and financial planning.
• Strong problem-solving and decision-making abilities.

This role offers a competitive salary, comprehensive benefits, and the chance to make a meaningful impact on patient lives within the **Thane, Maharashtra, IN** community.

Our client is seeking an experienced and dedicated Clinical Operations Manager to oversee the smooth and efficient running of their community health and social care services. This crucial role involves managing day-to-day operations, ensuring high standards of care, and leading a team of dedicated professionals. You will be responsible for resource allocation, staff supervision, and the implementation of operational policies and procedures designed to optimize patient and client outcomes.

Key Responsibilities:

• Supervising and mentoring a team of healthcare professionals, including nurses, social workers, and support staff.
• Managing daily operational schedules, ensuring adequate staffing levels and efficient service delivery.
• Developing, implementing, and monitoring adherence to clinical protocols and quality standards.
• Overseeing patient and client care pathways, ensuring a compassionate and effective approach.
• Managing budgets, including resource allocation, expense tracking, and financial reporting.
• Ensuring compliance with all relevant healthcare regulations and standards.
• Collaborating with external healthcare providers and community organizations to enhance service integration.
• Handling patient/client grievances and feedback to ensure continuous improvement.
• Implementing training programs and professional development opportunities for staff.
• Maintaining accurate and up-to-date records and documentation.

The ideal candidate will hold a relevant degree in Healthcare Management, Nursing, Social Work, or a related field, coupled with a minimum of 5 years of experience in a supervisory or management role within the healthcare or social care sector. Demonstrated leadership abilities, strong organizational skills, and a deep understanding of clinical operations are essential. Excellent communication, problem-solving, and interpersonal skills are required to manage a diverse team and interact effectively with clients and stakeholders. Familiarity with healthcare information systems and a commitment to continuous quality improvement are crucial. This is an on-site position based in Thane, Maharashtra, IN .

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
To enable AbbVie's emergence as a world class R&D organization, the Site Management and
Monitoring (SMM) Country/District COM plays a leadership role accountable for driving the business
of SMM within a Country/District(s) by providing oversight and direction to SMM staff; accountable
for the on time, within budget and quality delivery of the clinical studies. Promotes best practice;
identifies infrastructural improvements and implements action plan to ensure Clinical Field
Operations (CFO) and business objectives are successfully met; ensures alignment of local activities
with regional/global initiatives. The role reports into the Site M&M Leadership and serves as a single
point of accountability for the SMM deliverables within a Country/Disitrct(s) and influences and
aligns within Development Operations, and with Global Medical Affairs (GMA), and other key
stakeholders across the organization.
Responsibilities :
List up to 10 main responsibilities for the job. Include information about the accountability and
scope.
Manages/oversees site/country or district related activities as they relate to AbbVie clinical studies
(e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation,
regulatory/EC submissions startup, issue management, relationship management, monitoring, site
closure). Accountable for the on-time and within budget execution of all clinical trials within a
Country/District(s). Provide local regulatory and legal requirement expertise.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices
(GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to
quality standards in conducting clinical research. Monitor regulatory reforms and industry trends
within country / region. Conduct and/or implement impact analysis of all significant changes to
conform with updated regulatory / industry regulations affecting conduct of clinical studies.
Ensures audit and inspection-readiness at all times. Country contact for regulatory agency
questions related to monitoring processes and procedures. Drive CAPA preparation and
implementation.
Accountable for managing country/district resources including need identification, timely hiring and
allocation, and managing changes to hiring plan. Responsible for staff recruitment and retention
plans.
Accountable for functional budget planning and administration.
Provide leadership to the Country/District and be accountable for growth and development of a
world class workforce that role models AbbVie behaviors.
Drives a learning environment and ensures continuous improvement in Country/District(s)
performance by using innovative approaches, active analysis of Key Performance Indicators,
metrics and milestones. Driving simplicity in process and approach, and enhancing agility.
Accountable for ensuring SITE M&M leadership, collaboration and teamwork across all key
stakeholders within the Country(s).
May lead global Task Forces and Initiatives. Interacts with peers within the industry to stay
abreast of regulatory landscape, raise AbbVie' s profile in the R&D community. Accountable for
driving affiliate R&D Community goals in partnership with GMA.
Qualifications
Qualifications :
List required and preferred qualifications up to 10). Include education, skills and experience.Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing,
Pharmacy) preferred.
Site Monitoring Experience: Minimum 3 years. Preferably having monitored and/or managed a
study within a Country from start to close.
Experience in functional budget planning, resource planning & assignment, quality management in
a Country lead capacity preferred.
At least 2 years of experience in line management of staff including acquisition of talent,
performance management, growth and development, managing employee relations, coaching and
mentoring of staff and teams preferred.
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives
and drive smart decision making.
Excellent interpersonal skills with the ability to communicate persuasively and with clarity,
flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated
proactive and positive team player.
Exhibits strong planning and organizational skills and high level of flexibility in a dynamic
environment with experience leading (within country or region) projects with competing deadlines;
Experience across multiple Therapeutic Areas and Study Phases.
Demonstrating business ethics and integrity.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: