|
Reference Number:
MS_ClinMgr-EHNJ
Job Description:
Our client is a major pharmaceutical company and they are looking for a Expert Clinical Manager for a 6+ month position in East Hanover, NJ.
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.
1. Accountable for the writing of clinical protocols and related documents in collaboration with the CPL/CIL/MSE/CTH: 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.
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. Accountable for all internal clinical meetings related to the clinical trial(s).
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 Oncology Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local organizations.
4. In collaboration with the CPL/CIL/BSL/CTH 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 and other 3rd parties; manage interface with external vendors in cooperation with the Business Relationship Manager in the Contract Management Department.
6. 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.
7. Responsible for implementation of best practices and standards for trial management within OGD, including sharing lessons learned.
Requirements
- Advanced degree or equivalent education/degree in life science/healthcare is required. MD, PhD preferred.
? ¡Ý 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
? 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 organization is preferable.
Language(s): Fluent English (oral and written)
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "ClinMgr-EHNJ" IN THE SUBJECT LINE!
Experience Level:
Unspecified
Requirements:
|
