Global Medical Affairs Operations Manager - United States
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- Our company is looking for a driven, compassionate and innovative Global Medical Affairs Operations Manager for the Global Early Access and Investigator Sponsored Trial (IST) programs.
- This role is vital to achieving program goals and offers an opportunity to work on a variety of projects that reflect the company's patient focused mission.
- In this role, you may be responsible for the day to day management of expanded access clinical programs, ISTs, Early Access (Compassionate Use) requests, and Global Medical sponsored observational studies.
- This will be in addition to overall study management and the GMA operations team, vendors, clinical monitors and clinical trial sites.
- This position will also work closely with cross-functional teams to ensure that clinical trials, ISTs and early access requests are conducted in a timely fashion and in a manner compliant with SOPs, ICH/Good Clinical Practice (GCP)/regulatory guidelines, company goals, and budgets.
- This position is responsible for ensuring achievement of own or others? project goals and objectives.
- This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.
- Manages the operational aspects of expanded access clinical trials, Investigator Sponsored Trials (ISTs), Early Access (Compassionate Use) requests and Sponsored observational studies
- Participates in protocol, informed consent, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
- Prepares metrics and updates for management, as assigned
- Manages program and study timelines and budgets
- Proactively identifies potential issues/risks and recommends/implements solutions
- Participates in and facilitates CRO/vendor selection process for outsourced activities
- Ensure close collaboration with Development Operations to maximize current processes, SOPs including CRO selection, contract /budget processes and study implementation work instructions.
- Manages CRO/vendor interactions, providing sponsor oversight of operational activities (e.g., study management, monitoring, site management, project master files), develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Prepares and/or reviews/approves study-related documents as appropriate (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines), and site-related study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
- Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations
- Recommends and implements innovative process ideas to impact early access clinical trials management
- Organizes and manages internal cross-functional review meetings, team meetings, investigator meetings and other trial-specific meetings as required
- Serves as an internal liaison and resource for Investigators/Physicians and Medical Science Liaisons (MSLs)
- Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function, and may manage and mentor Medical Affairs Operations staff
- Participates in the development, review and implementation of departmental SOPs, processes, templates and tools
- Bachelor degree in a science or health related field required
- Leveling commensurate with number of years of experience
- 5+ years of relevant industry experience, with at least 3 years of direct clinical trial management experience at a Sponsor/Company or CRO
- Proven ability to provide clinical expertise to a clinical development program in a specified product area with experience in managing CROs, specialty labs, outside vendors and international trials
- Previous experience with IST, observational/interventional studies, and EAP management required
- Late Phase or Phase IV experience preferred, but not required
- Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required
- High degree of customer focus towards internal and external stakeholders; strong collaboration skills, excellent planning skills and able to manage multiple projects with time demands
- Minimal travel may be required