What Jobs are available for Research Associate in Mumbai?

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary**
The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.
**Duties/Responsibilities:**
+ Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
+ Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
+ Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.
+ Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.
+ Motivate and influence sites to meet study objectives, including enrollment and retention goals.
+ Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
+ Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
+ Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
+ Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
+ Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
+ Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
+ Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
+ Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
+ Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
+ May support Ethics Committee submissions, ICF reviews, collection of documents to/from site
+ Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.
+ Support coordination of site activities related to database locks to ensure timelines are met as required locally.
+ Perform timely site closure activities when all required protocol visits and follow-up are completed.
**Qualifications:**
+ Bachelor's degree required, preferably within life sciences or equivalent
+ Valid driver's license (as locally required)
**Experience:**
+ Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role.
+ Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
+ Experience in the drug discovery/development process.
**Competencies:**
+ Knowledge and understanding of clinical research processes, regulations and methodology
+ Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
+ Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities ( Analytical thinking/critical thinking skills. Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions ( Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment
+ Organization and time management skills
+ Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders
+ Good verbal and written communication skills (both in English and local language)
+ Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.)
+ Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning
+ Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
+ Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity
**Software that must be used independently and without assistance:**
+ Microsoft Suite
+ Clinical Trial Management Systems (CTMS)
+ Electronic Data Capture Systems (eDC)
+ Electronic Trial Master File (eTMF)
+ RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :33:49.828 UTC
**Location:** Mumbai-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Our client, a leading pharmaceutical innovator, is seeking a highly skilled and experienced Senior Clinical Research Associate (SCRA) to join their dynamic team in Mumbai, Maharashtra . This role offers a unique opportunity to contribute to cutting-edge drug development programs and ensure the highest standards of clinical trial execution. The SCRA will be responsible for the overall management of clinical trial sites, ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines. Key responsibilities include site selection and initiation, ongoing site monitoring (remote and on-site visits), data review and query resolution, and ensuring timely reporting of trial progress and adverse events. The successful candidate will act as the primary liaison between the investigational sites and the sponsor, fostering strong relationships and facilitating effective communication. They will also be involved in training site staff, addressing site-specific issues, and ensuring all necessary documentation is accurately maintained in site and study files. This role requires a proactive approach to problem-solving, excellent organizational skills, and a deep understanding of the pharmaceutical research landscape. The SCRA will play a crucial role in ensuring the integrity, accuracy, and quality of data collected during clinical trials, which is paramount to bringing new therapies to patients. Furthermore, they will contribute to the development and implementation of site-specific action plans to address any deviations or deficiencies identified during monitoring activities. A strong commitment to ethical research practices and patient safety is essential. The ideal candidate will possess exceptional attention to detail, strong analytical skills, and the ability to work independently while collaborating effectively with a cross-functional team. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is highly desirable. This position is ideal for a motivated professional looking to advance their career in clinical research within a supportive and growth-oriented environment. The hybrid work model allows for a balance between focused remote work and essential in-person collaboration at our client's facilities in Mumbai, Maharashtra . Join us and make a significant impact on the future of healthcare.
Responsibilities:

• Oversee and manage multiple clinical trial sites ensuring adherence to protocols and regulations.
• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure data accuracy and integrity through regular source data verification and query resolution.
• Maintain effective communication channels between study sites, regulatory bodies, and internal teams.
• Identify, document, and resolve site-related issues and discrepancies.
• Train site personnel on study protocols, procedures, and regulatory requirements.
• Ensure timely submission of essential documents and regulatory filings.
• Manage study timelines and milestones at the site level.
• Promote patient safety and ethical conduct throughout the trial.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) or similar role in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and local regulatory requirements.
• Proven experience in therapeutic areas relevant to ongoing drug development.
• Excellent verbal and written communication skills.
• Strong organizational and time management abilities.
• Proficiency in clinical trial management software and EDC systems.
• Ability to travel to investigational sites as required.

Our client, a leading pharmaceutical company, is seeking an experienced and meticulous Lead Clinical Research Associate (CRA) to join their team in Mumbai, Maharashtra, IN . This critical role will oversee and manage clinical trial activities, ensuring compliance with regulatory requirements, ethical standards, and company protocols. The Lead CRA will be responsible for the initiation, monitoring, and closure of clinical trial sites, providing guidance and support to junior CRAs and site personnel. You will play a key role in the development and implementation of clinical trial protocols, ensuring the integrity of data collected and the safety of study participants. Responsibilities include conducting site visits, verifying source data, ensuring adherence to Good Clinical Practice (GCP) guidelines, and managing site-related documentation. The Lead CRA will also be instrumental in identifying and resolving study-related issues, communicating effectively with investigators and study teams, and contributing to the overall success of drug development programs. This position requires exceptional organizational skills, strong analytical abilities, and a deep understanding of pharmaceutical research and development processes. The ideal candidate will possess excellent leadership qualities, the ability to mentor and train staff, and a proven track record of successful clinical trial management. You will collaborate closely with internal teams, including regulatory affairs, data management, and medical affairs, to ensure a cohesive approach to clinical development. This role offers a challenging and rewarding opportunity to contribute to bringing innovative therapies to market.

Key Responsibilities:

• Lead and manage all aspects of clinical trial site operations, including initiation, monitoring, and closure.
• Ensure compliance with ICH-GCP guidelines, regulatory requirements, and study protocols.
• Conduct site visits (remote and on-site) to assess study progress, data accuracy, and patient safety.
• Train and mentor junior Clinical Research Associates and site staff.
• Develop and review clinical study protocols, case report forms (CRFs), and other trial-related documents.
• Identify and resolve site-level issues and discrepancies promptly and effectively.
• Manage communication between study sites, internal teams, and regulatory authorities.
• Oversee drug accountability and management at clinical trial sites.
• Prepare and present study progress reports to management and relevant stakeholders.
• Contribute to the selection and qualification of new clinical trial sites and investigators.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. Advanced degree preferred.
• Minimum of 7 years of experience as a Clinical Research Associate, with at least 2 years in a lead or supervisory role.
• Extensive knowledge of ICH-GCP, FDA, and other relevant regulatory guidelines.
• Proven experience in managing multiple clinical trials and sites simultaneously.
• Excellent understanding of clinical trial processes and documentation.
• Strong leadership, communication, and interpersonal skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel as required for site visits.

Our client, a leading innovator in pharmaceutical research and development, is seeking a highly skilled and experienced Senior Clinical Research Associate to join their dynamic team in Mumbai, Maharashtra, IN . This pivotal role will involve overseeing and managing clinical trials to ensure compliance with regulatory standards and company protocols. You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data integrity and patient safety throughout the trial lifecycle.

Key responsibilities include developing clinical trial protocols, monitoring trial progress, and identifying and resolving site-level issues. You will also be tasked with training and mentoring junior research staff, building strong relationships with investigators and site personnel, and ensuring adherence to Good Clinical Practice (GCP) guidelines. The ideal candidate will possess a strong understanding of drug development processes, regulatory requirements (e.g., FDA, EMA), and a proven track record in managing complex clinical trials. This is an exciting opportunity to contribute to groundbreaking medical advancements in a collaborative and supportive environment. The position requires excellent communication, analytical, and problem-solving skills, with the ability to work effectively both independently and as part of a cross-functional team. A background in life sciences, nursing, or a related field, coupled with extensive experience in clinical research, is essential.

Responsibilities:

• Plan, implement, and manage clinical trial activities according to approved protocols.
• Conduct site visits (initiation, monitoring, close-out) to ensure compliance and data accuracy.
• Train and supervise site staff on trial procedures and regulatory requirements.
• Manage trial budgets and timelines effectively.
• Prepare and submit regulatory documents and reports.
• Identify, assess, and resolve clinical trial issues and deviations.
• Collaborate with internal teams, investigators, and external stakeholders.
• Ensure data quality and integrity by reviewing source documents and case report forms.
• Stay abreast of industry trends, regulatory updates, and best practices in clinical research.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's degree preferred.
• Minimum of 5 years of progressive experience in clinical research, with at least 2 years in a Senior CRA role.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven ability to manage multiple clinical trials simultaneously.
• Excellent interpersonal, communication, and negotiation skills.
• Strong analytical and problem-solving capabilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel to clinical sites as required.

Our client, a leading pharmaceutical company, is actively seeking a Senior Clinical Research Associate (CRA) to join their esteemed team. This is a fully remote position, enabling you to contribute to groundbreaking research from the convenience of your home office. As a Senior CRA, you will play a pivotal role in managing and monitoring clinical trials, ensuring adherence to protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as maintaining comprehensive study documentation. The ideal candidate possesses a strong scientific background, meticulous attention to detail, and excellent interpersonal skills to effectively communicate with investigators, site staff, and internal study teams. Your responsibilities will include verifying data accuracy, resolving queries, and ensuring the safety and well-being of study participants. You will also be involved in protocol development, providing input on study design and feasibility. A bachelor's degree in a life science, nursing, or a related field is a must. A minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry is required, with demonstrated success in managing multiple clinical trials across different therapeutic areas. Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems is essential. Strong knowledge of FDA regulations and ICH-GCP guidelines is also critical. This remote role demands a high degree of self-motivation, excellent organizational skills, and the ability to travel to sites as needed (following all safety protocols). Join our innovative team and contribute to the advancement of life-saving therapies, working remotely while supporting critical research in **Mumbai, Maharashtra, IN**.

Our client, a leading name in the **Pharmaceutical** industry, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their team in **Mumbai, Maharashtra, IN**. This hybrid role involves overseeing clinical trials, ensuring adherence to protocols and regulatory guidelines, and monitoring subject safety and data integrity. The ideal candidate will have a strong understanding of clinical trial processes, excellent organizational skills, and the ability to conduct site visits and foster positive relationships with investigators and site staff. This position is crucial for advancing innovative treatments through well-managed clinical studies.

Key Responsibilities:

• Monitor clinical trial sites to ensure compliance with Good Clinical Practice (GCP) guidelines, protocols, and regulatory requirements.
• Perform site initiation visits, interim monitoring visits, and close-out visits.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Ensure subject safety and reporting of adverse events.
• Build and maintain strong working relationships with investigators, study coordinators, and site staff.
• Provide training and ongoing support to clinical trial sites.
• Manage study supplies and investigational product at trial sites.
• Prepare monitoring reports and ensure timely resolution of site issues.
• Collaborate with internal teams, including project management, data management, and medical affairs.
• Participate in investigator meetings and other relevant industry events.
• Maintain accurate and up-to-date trial documentation.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 3-5 years of experience as a Clinical Research Associate (CRA).
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience in therapeutic areas such as (mention relevant areas, e.g., oncology, cardiology, neurology) is a plus.
• Excellent monitoring skills, including source data verification and query resolution.
• Strong communication, interpersonal, and organizational skills.
• Ability to travel to clinical trial sites as required.
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Detail-oriented with a strong commitment to data accuracy and patient safety.
• Ability to work effectively in a hybrid environment, balancing remote administrative tasks with on-site responsibilities.
• Self-motivated and able to manage workload independently.

This hybrid role offers a significant opportunity to contribute to groundbreaking pharmaceutical research. You will work with a dedicated team focused on bringing life-changing therapies to patients. Our client is committed to fostering a collaborative and professional work environment. Join a company that values scientific rigor and makes a real difference in healthcare.

Our client, a leading pharmaceutical research organization, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their team in Mumbai, Maharashtra, IN . This hybrid role offers a blend of remote flexibility and on-site responsibilities, focusing on ensuring the quality and integrity of clinical trials. As a CRA, you will be responsible for monitoring clinical trial sites, verifying data accuracy, ensuring compliance with protocols and regulatory requirements, and supporting investigators and study staff. The ideal candidate will have a strong background in clinical research, excellent understanding of Good Clinical Practice (GCP) guidelines, and exceptional attention to detail. You will play a crucial role in the successful execution of clinical studies, contributing to the development of life-saving medications. This position requires strong organizational skills, effective communication, and the ability to manage multiple tasks and sites efficiently. Your contribution will be vital in advancing pharmaceutical innovation and bringing new therapies to patients.Key Responsibilities:

• Conduct site initiation, monitoring, and close-out visits in accordance with study protocols and GCP.
• Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
• Ensure compliance with study protocols, investigational plans, and applicable regulatory requirements (e.g., FDA, EMA, DCGI).
• Train and support site staff on study procedures, data collection, and regulatory compliance.
• Manage communication between study sites, the sponsor, and other stakeholders.
• Identify and resolve site-level issues and escalate critical matters as needed.
• Ensure timely submission of study-related documents and reports.
• Maintain accurate and up-to-date study documentation and trial master files.
• Participate in protocol review and development as required.
• Contribute to the overall quality and success of the clinical trial program.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's degree preferred.
• Minimum of 3-5 years of experience as a Clinical Research Associate.
• In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
• Proven experience in conducting site monitoring visits and data verification.
• Excellent understanding of clinical trial processes and documentation.
• Strong organizational, time management, and multitasking skills.
• Exceptional written and verbal communication skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and collaboratively in a hybrid work environment.
• Attention to detail and a commitment to data accuracy and patient safety.

This is an excellent opportunity for an experienced CRA to contribute to groundbreaking research within a reputable pharmaceutical company. If you are passionate about clinical research and meet the qualifications, we encourage you to apply.

Our client is seeking a meticulous and experienced Senior Clinical Research Associate (CRA) to join their prestigious pharmaceutical team in Mumbai, Maharashtra, IN . This role is integral to overseeing and managing clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. You will be responsible for monitoring trial sites, collecting data, ensuring patient safety, and maintaining comprehensive trial documentation. The ideal candidate possesses a strong understanding of pharmaceutical development, clinical trial methodologies, and regulatory affairs.

Key Responsibilities:

• Conducting site initiation, routine monitoring, and close-out visits for clinical trials.
• Ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
• Verifying the accuracy, completeness, and integrity of clinical trial data.
• Monitoring patient safety and reporting adverse events promptly.
• Managing investigational product accountability and drug supply at trial sites.
• Maintaining effective communication with investigators, study coordinators, and internal project teams.
• Resolving site-level issues and providing guidance to site personnel.
• Ensuring proper trial documentation is maintained at investigator sites.
• Training new CRAs and providing mentorship.
• Participating in the development and review of study protocols and case report forms (CRFs).
• Preparing and submitting monitoring reports and other necessary documentation.
• Ensuring timely recruitment of subjects according to the protocol.
• Liaising with ethics committees and regulatory authorities as needed.
• Contributing to the overall success of clinical development programs.

Required qualifications include a Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. A Master's degree is a plus. A minimum of 5-7 years of experience as a Clinical Research Associate, with a proven track record in monitoring pharmaceutical trials, is essential. Strong knowledge of ICH-GCP guidelines and regulatory requirements is mandatory. Excellent organizational, analytical, and communication skills are required. Ability to travel to trial sites as needed is expected. Experience with various therapeutic areas is advantageous.

Our client is seeking an experienced and meticulous Senior Clinical Research Associate (CRA) to join their dynamic pharmaceutical team in Mumbai, Maharashtra, IN . This role involves overseeing clinical trials to ensure data integrity, patient safety, and adherence to regulatory guidelines. As a Senior CRA, you will be responsible for site selection, initiation, monitoring, and close-out visits, as well as managing relationships with investigators and study staff. You will play a crucial role in ensuring that trials are conducted according to the protocol, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. Your responsibilities will extend to verifying the accuracy and completeness of source documents, managing drug accountability, and ensuring the timely submission of trial-related documentation. This position requires a strong understanding of pharmaceutical research methodologies, excellent communication and interpersonal skills, and the ability to work independently while collaborating effectively with cross-functional teams. The ideal candidate will possess a proven track record of successfully managing multiple clinical trials simultaneously, demonstrating strong problem-solving abilities and a commitment to excellence. You will be expected to contribute to the development and refinement of clinical trial protocols and monitoring plans. This hybrid role offers a blend of on-site responsibilities and remote flexibility, allowing for effective management of study sites and associated administrative tasks. Attention to detail, critical thinking, and a proactive approach to identifying and resolving potential issues are paramount. The ability to travel to study sites as needed is also a requirement. If you are a dedicated professional passionate about advancing pharmaceutical research and improving patient outcomes, we encourage you to apply.

Key Responsibilities:

• Conduct pre-study, initiation, interim, and close-out visits at clinical trial sites.
• Monitor study conduct to ensure compliance with protocol, GCP, and regulatory requirements.
• Verify source data and ensure its accuracy against case report forms (CRFs).
• Manage investigational product accountability and ensure proper storage and dispensing.
• Build and maintain strong relationships with investigators, site staff, and other stakeholders.
• Identify, document, and track study-related issues and deviations.
• Prepare and submit site monitoring reports in a timely manner.
• Ensure timely resolution of site-specific issues and action items.
• Provide training and guidance to site staff on study procedures and regulatory compliance.
• Contribute to the development of study documents, including monitoring plans.

Qualifications:

• Bachelor's degree in a life science, nursing, or related field. Advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Proven experience in monitoring multiple clinical trials across different therapeutic areas.
• Excellent written and verbal communication skills.
• Strong organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel up to 50% of the time to various study sites.