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Post: Clinical Trial Head
Job Description:
Job Purpose (State in one sentence the overall objective of the job)
Accountable for all aspects of assigned CD&MA clinical trials (Phase II through lifecycle management) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for program level activities as assigned.
Major Accountabilities (Describe 8-12 main activities)
1. Accountable for the writing of clinical protocols and related documents in collaboration with the GBMD/PSL/MSE: lead the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
2. Participate in development of effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings to support Novartis local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical trial.
3. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings, report study progress and issues with their resolution plan to International Clinical Teams; lead trial level interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
4. In collaboration with the GBMD/PSL/BSL and/or MSE, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
5. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department.
6. Forecast trial resources needs (headcount and external costs): accountable for the development, management and tracking of trial budget working closely with the TA program operations group. Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TA management to ensure appropriate line function allocation.
7. In collaboration with the CRDD, assign short to mid-term responsibilities to CM who assist in the planning, conduct and reporting of clinical trials; independently manage the day-to-day interactions with the CMs; contribute to talent and career development of TA staff; provide input to performance evaluations and promotion recommendations of the CMs.
8. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
9. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier.
10. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
11. Participate in the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for CD&MA training programs.
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Candidate Profile:
Ideal Background (State the minimum and desirable education and experience level)
Education:
Advanced degree or equivalent education/degree in life science/healthcare is required. MD, PhD preferred.
Languages:
Fluent English (oral and written)
Experience:
• ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
• Experience in developing effective relationships with key investigators.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
• Advanced knowledge of the assigned Therapy Area is preferable.
• Previous experience within a local medical organisation is preferable
Additional Information:
Experience: min. 4 Years
Location: Hyderabad
Education: B.Pharm, B.Sc, MBBS, MD, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D, CR
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 76733BR
End Date: 20th Sept., 2011
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