Medical Affairs, Research Manager
|Job Title:||Medical Affairs, Research Manager|
|Location:||North Carolina, USA|
|Contact Name:||Pavlina Bullaj|
|Job Published:||August 21, 2017 17:39|
Medical Affairs, Research Manager
Location: East Coast
As the Medical Affairs, Research Manager you will be responsible for the management of research sponsored or supported by the clients Medical Affairs. This can include sponsored Phase IIIB/IV and non-interventional studies, as well as Investigator-initiated Studies. You will be responsible for ensuring that sponsored research is aligned with global medical affairs objectives and will liaise with regional personnel to monitor adherence to GCP and study progress, and provide budgetary oversight.
The responsibilities of this job include, but are not limited to, the following:
Phase IIIB/IV and Non-Interventional Studies.
- Support the clients product life cycle development strategy and post-approval research commitments by helping develop and oversee the company's program of Phase IIIB/IV and non-interventional studies
- Coordinate and provide medical input into regional study development, including concept, synopsis, and protocol development
- Organize and manage Post-Approval Research Committee
- Monitor regional study execution, including budget, study progress, study completion, and CSR development
- Manage Phase IIIB/IV and Non-Interventional Studies budget proposals, contracts, and expenditures
- Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations, and preparing reports to the management and medical community.
Investigator-Initiated Studies (IIS)
- Provide medical input on IIS strategy and objectives
- Be the administrator for the IIS process, including:
- Coordinating and managing the IIS proposal submission process
- Managing the review process for IIS proposals
- Serving as the point of contact for Principal Investigator communications
- Coordinating research agreements and drug and/or funding delivery
- Collaborating on drug and/or funds reconciliation
- 7+ years' experience in pharmaceutical or biotech industries, Medical Affairs experience preferred
- 5+ years Phase III and Phase IV research experience
- 5+ years' experience in Investigator Initiated Studies or as a PI in academic research
- Medical Monitor or Scientific Officer experience on company-sponsored trials preferred
- Budgets, contracts, product/supply management, and reconciliation experience preferred
- Working in and/or strong understanding of substance use disorder therapeutic area preferred
- Advanced degree within a scientific discipline (Master's degree with experience; PharmD, PhD, or MD preferred)
- Outstanding leadership, collaboration, presentation, written, and oral skills required
- Intellectual strength, analytical ability, and high professional standards in designing, conducting and evaluating clinical research
- Collaborative and flexible in personal interactions at all levels of the company
- Ability to work proactively and effectively, with exceptional creative problem solving skills
If this is something you would be interested in, please apply to the role directly or alternatively you can send me your availability with an updated resume to firstname.lastname@example.org for more information.
I look forward to speaking to you!
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