Clinical Study Resource II

Duration: 12 Months+

• Manage Medical Affairs studies, including Interventional studies & observational studies, survey-based research (primary use of data), or retrospective chart reviews and external database analysis studies (secondary use of data)
• Responsible for strategic operational planning, oversight, and execution of studies.
• Accountable for effective management of budgets, timelines and resources for assigned clinical studies, and implementation of appropriate standards and processes to ensure clinical study quality
• Responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies
• This position may oversee management of multiple studies.

Essential Job Responsibilities:

Evidence Generation Strategy

• Direct studies to support budgeting and planning, synopsis/protocol coordination, vendor selection and oversight, alignment of timelines and plans
• Create and monitor reports on key performance metrics and status of data generation activities aligned with Core Medical Plans
• Evaluate clinical trial risks; prepare and execute contingency plans for operational risk including patient recruitment, regulatory environment and data quality.
• Performs strategic analysis of project status and issues, ensuring robust risk mitigation strategies are in place, and communicates to appropriate stakeholders. Anticipates complex obstacles and implements solutions or oversees implementation of solutions by vendor.

Evidence Generation Execution

• Lead feasibility assessment and selection of countries and sites for study conduct
• Manage and lead cross-functional study teams, including vendors
• Responsible for financial oversight of the program(s), requiring a strong financial acumen; proactively partners cross-functionally for updates to timelines and budgets.
• Development of RFPs, selection of CROs/vendors
• Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to MA leadership and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
• Provide oversight and direction to study team members for study deliverables

Qualifications:

Required

Educational Background:

• Bachelor’s in Sciences or equivalent in science or health-related field with at least 7 years vendor oversight and clinical trial management experience in CRO, Pharmaceutical or Biotech company

Key Competencies:

• Strong clinical study management skills (including project and financial management)
• Experience with audits and regulatory inspections
• Excellent leadership, negotiation, and management skills
• CRO/vendor management experience, including experience in audits and inspections.
• Business-fluent English
• Demonstrate strong organizational skills including ability to prioritize
• Ability to work virtually

Shift: Day