Crma

Work Schedule

Environmental Conditions

Job Description

As a PPD FSP Clinical Research medical Advisor (CRMA) you may support a variety of designated therapeutic areas including Cardio-Renal-Metabolic/Immunology/Neuroscience.

CRMAs will be accountable for all country clinical/medical aspects associated with Development and prioritized Research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. (This may involve work across several countries).

It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs aligning technical operations & strategy.

CRMAs gather inform and act on clinical/medical/scientific insights for clinical trial concept sheets/protocols Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation. They also drive the identification and involvement of qualified investigators with greatest recruitment potential identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.

Working in close collaboration with other country functions (e.g. clinical trial operations Medical Affairs and Patient Engagement) you will actively contribute to successful allocation fast clinical trial start-up timely recruitment early identification of potential delays and development and implementation of mitigation plans.

Responsibilities include:

Validating study designsand makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.

• Actively contributestoscientific/clinical/medicalaspects of the start-up phase to ensure fast clinical trial site start-up.
• Provides clinical/medical expertiseto clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
• Providesscientific/clinical/medicalexpertiseduring interactions with Country/Cluster external Experts (e.g. Regulatory Authorities Medical Experts Advisory Boards Patient Advocacy Groups etc.).
• Develops clinical/medical trial planstaking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation.
• Support and partner with Sponsor Stakeholders as needed regarding clinical trials as thescientific/clinical/medicalexpert (important internal stakeholders will be Clinical Trial Team Regulatory Affairs Medical Information Medical Affairs Marketing Patient Access Health Economics and Outcomes Research (HE&OR) clinical trial operations etc.)
• Gather inform and acton insights from clinical trial Investigators/site staff Medical Experts patients and payers with Sponsor Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
• Carries accountabilityfor adherence to safety standards clinical data quality for the Country/Cluster and provides generalscientific/clinical/medicalsupport for safety issues

Essential Requirements:

• Scientific degree M.D. Ph.D. or Pharm.D. (M.D. is preferred) ideally with experience in clinical development within pharmaceutical industry or clinical practice.
• Sound understanding of the overall clinical development process and ICH/GCP principles.
• Fluent English language skills (full proficiency in speaking and in writing)
• Agility to move quickly across different therapeutic areas and indications as well as ability to prepare and deliver high quality presentations.

Location:

Remote local with travel as needed up to 50%.