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Clinical Research Associate
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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:** :31:19.228 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.
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                    Clinical Research Associate
 
                        Posted 1 day ago
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Job Description
**YOUR TASKS AND RESPONSIBILITIES:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**WHO YOU ARE:**
+ Minimum qualification requirement is to have a Bachelor's or Masters degree in a health(1)related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
+ Relevant experience of 1-5 years minimum in the field of Clinical Research
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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                    Clinical Research Associate
Posted today
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Job Description
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                    Clinical Research Associate
Posted today
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                    Clinical Research Scientist
Posted 1 day ago
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Responsibilities:
- Design and develop comprehensive clinical trial protocols, including study objectives, endpoints, patient populations, and statistical analysis plans.
- Oversee the operational aspects of clinical trials, ensuring data integrity, patient safety, and compliance with Good Clinical Practice (GCP) guidelines and other relevant regulations.
- Analyze and interpret complex clinical data, generating reports and presentations for internal stakeholders, regulatory agencies, and scientific publications.
- Collaborate with principal investigators and study sites to ensure effective trial execution and resolution of study-related issues.
- Contribute to the development of Investigator's Brochures, clinical study reports, and other regulatory submission documents.
- Stay abreast of scientific literature, therapeutic area advancements, and competitive landscape to identify new research opportunities and strategies.
- Provide scientific and clinical expertise to project teams, including medical, marketing, and manufacturing departments.
- Manage external collaborations with academic institutions, contract research organizations (CROs), and other partners.
- Ensure the quality and accuracy of data through regular reviews and queries.
- Participate in the preparation of abstracts, manuscripts, and presentations for scientific congresses.
- Ph.D. or M.D. in a relevant life science discipline (e.g., Pharmacology, Biology, Biochemistry, Pharmacy) or a Master's degree with extensive relevant experience.
- Minimum of 5 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- In-depth understanding of drug development processes, clinical trial design, statistical methodologies, and regulatory requirements (e.g., ICH-GCP, FDA, EMA).
- Proven ability to design and conduct complex clinical trials.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Demonstrated experience in data analysis and interpretation, including statistical analysis planning.
- Ability to work independently and manage multiple projects in a remote setting.
- Proficiency in medical writing and preparing scientific documents.
- Experience in a specific therapeutic area (e.g., oncology, cardiology, neurology) is a plus.
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                    Clinical Research Associate
Posted 3 days ago
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                    Clinical Research Associate
Posted 4 days ago
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Key responsibilities include initiating, monitoring, and closing out clinical trial sites. You will be responsible for conducting site visits, reviewing source documents, and ensuring that study protocols are followed accurately. The CRA will serve as the primary point of contact between the study sites and the sponsor, addressing any issues or concerns that may arise. You will also be involved in training site personnel on study procedures and requirements. The ideal candidate will possess strong knowledge of clinical trial processes, regulatory requirements, and data management. Excellent organizational, communication, and interpersonal skills are essential. You should be adept at problem-solving and possess a keen eye for detail to ensure data integrity and patient safety. The ability to travel to study sites is a requirement for this hybrid role.
Responsibilities:
- Conduct pre-study, initiation, interim, and close-out visits for clinical trial sites.
- Monitor clinical trial sites to ensure adherence to protocols, SOPs, and regulatory requirements (GCP).
- Verify the accuracy, completeness, and validity of clinical trial data.
- Review source documents and compare them with case report forms (CRFs).
- Train site personnel on study-specific procedures and regulatory compliance.
- Act as a liaison between the study sites and the sponsor organization.
- Identify, document, and resolve study-related issues and deviations.
- Ensure timely submission of all required study documentation.
- Report on site performance and escalate issues as necessary.
- Contribute to the development and maintenance of study protocols and other relevant documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role.
- In-depth knowledge of clinical trial processes, GCP, and regulatory guidelines.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong understanding of medical terminology and disease states.
- Excellent organizational, time management, and problem-solving skills.
- Exceptional written and verbal communication skills.
- Ability to travel to clinical trial sites as required.
- Detail-oriented and able to maintain high standards of accuracy.
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Clinical Research Associate
Posted 5 days ago
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                    Clinical Research Associate
Posted 6 days ago
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Key Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits to assigned clinical sites.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Ensure adherence to the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulations.
- Identify, evaluate, and select potential clinical investigators and sites.
- Train and provide ongoing support to site staff regarding study procedures and requirements.
- Manage communication between study sites, the sponsor, and other relevant parties.
- Resolve site-level issues and escalate critical matters to the project manager as needed.
- Ensure timely submission of all required regulatory and ethical documentation from sites.
- Oversee subject recruitment and retention efforts at assigned sites.
- Prepare monitoring visit reports and follow up on action items.
- Maintain accurate and up-to-date site files and study documentation.
- Contribute to the development and review of study-related documents, such as protocols and case report forms.
- Ensure the safety and well-being of study participants.
- Manage study timelines and deliverables for assigned sites.
- Stay abreast of current trends and developments in clinical research and pharmaceutical development.
- Bachelor's degree in a life science, nursing, or related discipline. Advanced degree preferred.
- Minimum of 2-3 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven experience in site monitoring and data verification.
- Excellent understanding of clinical trial processes and drug development.
- Strong organizational and time management skills.
- Exceptional written and verbal communication abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and remotely, with a high degree of self-discipline and accountability.
- Willingness to travel to sites as required (if applicable, but this role is remote-first).
- Critical thinking and problem-solving skills.
- Detail-oriented with a commitment to quality and accuracy.
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                    Clinical Research Scientist
Posted 6 days ago
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Job Description
Responsibilities:
- Design, develop, and implement clinical trial protocols in accordance with regulatory guidelines (e.g., ICH-GCP) and scientific objectives.
- Oversee the conduct of clinical trials, including site selection, initiation, monitoring, and close-out activities.
- Collaborate with cross-functional teams, including medical affairs, regulatory affairs, data management, and biostatistics.
- Analyze and interpret clinical trial data, preparing comprehensive reports for regulatory submissions and scientific publications.
- Ensure compliance with all applicable regulations, ethical standards, and company policies.
- Manage relationships with investigators, clinical research coordinators, and other external stakeholders.
- Contribute to the scientific strategy for drug development programs.
- Prepare and deliver scientific presentations and publications.
- Mentor junior researchers and contribute to a culture of continuous learning and improvement.
- Stay abreast of the latest scientific advancements and therapeutic area developments.
- Ph.D. or M.D. in a life science discipline (e.g., Pharmacology, Biology, Biochemistry, Medicine).
- Minimum of 7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Extensive knowledge of clinical trial design, execution, and data analysis.
- Proven experience in protocol development and regulatory submissions.
- Strong understanding of Good Clinical Practice (GCP) and other relevant regulatory requirements.
- Excellent scientific writing and communication skills.
- Demonstrated ability to work effectively in a remote, collaborative environment.
- Strong project management and organizational skills.
- Experience in (Specific therapeutic area, e.g., Oncology, Cardiology) is highly desirable.
- Proficiency in clinical trial management systems and statistical software.
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