Associate Medical Director - CNS
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The Associate Medical Director functions in the role of a Medical Monitor and reports directly to the Chief Medical Officer and is responsible for reviewing safety data and ensuring the safety of study participants in clinical studies in a team setting while working throughout the product's lifecycle. Helping to ensure that products are utilized effectively, serving as a scientific peer and providing resources within the medical community and are scientific experts to internal colleagues as needed. The Associate Medical Director has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial
Here’s What You’ll Do:
- Provide medical review, assessment and interpretation of clinical and safety data to ensure proper clinical trial site oversight with an eye toward safety and quality
- Ensure safety review is in compliance with appropriate SOPs and Data Safety Monitoring Plans
- Supporting the Safety Department in the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting and assuring compliance with global and local regulatory requirements.
- Coordinate with researchers globally to conduct clinical trials, providing support in their efforts and coordinating safety communications between key players
- Maintain effective communication and facilitate the exchange of information within the Safety and Clinical Operations Department, MPBC staff and external groups including CRAs, Medical Monitors and Directors, other Department Heads, Site Staff, Data Management, Biostatistics, Regulatory, Finance, Logistics, Adherence Raters and other collaborators
- Mentor CTLs, CRAs, CSAs and Interns in study safety and compliance
- Provide input and assist in training in the creation and review of study training material or other formal training at site and at the study team level, especially as it pertains to safety and quality
- Review monitoring trip reports, on an as needed basis, on status of each of the assigned studies and make any necessary recommendations for contingency planning where safety or quality is concerned
- Review the trending of monitoring findings (deviations/data listings/communications) to ensure resolution of safety and medical issues including risk mitigation ensuring proper retraining of clinical and site staff as appropriate
- Ensure the consistent quality of study data by reviewing data listings and patient profiles, ensuring AEs, AESI, SAEs, concomitant medications, and inter current illnesses are reviewed for consistency with medical diagnosis, action taken and reported in accordance with study protocols, providing feedback and ensuring proper retraining of clinical and site staff as appropriate
- Ensure timely reporting, escalation and review of important AEs and SAEs
- Track study progress using tracking tools, ensuring timely and quality updates
- Act as the SME in the development of the Clinical Study Report for assigned studies
Here’s What You’ll Bring to the Table:
- Clinical degree (MD, DO, NP, PA, PharmD) with strong leadership skills, preferably with 2-5 years direct experience in the pharmaceutical industry or clinical research, preferably in a medical monitoring role.US and EU experience preferred.
- Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs.
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
- At least 1 year experience as Medical Monitor directly responsible for assigned clinical trials
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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