Duration: 12Months
Payrate: £46 - £49/hr PAYE
(Senior) Manager, Medical Affairs – Real-World Evidence Generation
(Senior) Manager, Medical Affairs – Real-World Evidence Generation assists in developing and conducting observational research studies. The (senior) Manager works cross-functionally providing content expertise and tactical support for the execution of evidence generation across the region.
Job Description
* Study concept development and execution of incidence/prevalence, burden of Illness and natural history of disease assessment for business and development and early development indications.
* Tactical support for cross-functional RWE development including registries, burden of Illness/natural history of disease for regulators, payers and clinicians.
* Strategic and tactical support for developing RWE historical control and methods.
* Adapt performance metrics and dashboards for RWE project within their therapeutic area.
Possess adequate communication skills and comprehensive understanding of strategies to translate observational research methods and results to diverse audiences.
Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research.
Write protocols, SAPs, clinical study reports and review study documents.
Provide clinical expertise and input for regulatory filings as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures.
Interact with clinical investigators and thought leaders.
Provide leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial).
Qualifications
Scientific degree (i.e. MSc, PhD, MD or PharmD) and experience in biostatistics, epidemiology, health economics or outcomes research experience
Preferred Qualifications
* PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar.
* Experience in Hematology and/or Oncology.
* Formal training in Epidemiology/Health Services Research.
* Significant experience in observational research study management and data analytics, either within industry or with an observational research consulting firm.
* Experience conducting/reviewing systematic literature reviews.
* Advanced knowledge in observational research design.
* Excellent interpersonal communication and study management skills.
* Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings.
* Ability to work effectively in a constantly changing, diverse, and matrix environment.
* Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel).
* Able to conduct analyses using statistical software such as R, SAS, SPSS or Stata.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter's Details:
Name: Tejasva
Email: tejasva@ustechsolutionsinc.com
Internal ID: 25-00224