What are the responsibilities and job description for the Medical Monitor position at Actalent?
Qualifications
Must have a minimum of 10 years of industry experience in Pharmaceutical or CRO companies AND a minimum of 5 years in management
Must have an MD degree AND be Board Certified or Eligible
Must have Oncology experience
Proficient in clinical research and protocol design, with experience in Phase I-III clinical trials
Remote Director of Medical Monitoring
Will lead the medical oversight of the clinical studies and ensure subject safety, site medical compliance with protocol and ICH-GCP requirements, and overall
scientific integrity and quality of the clinical studies in the US.
Proactively provide the medical leadership and scientific input to improve the project quality in the function of medical science, pharmacovigilance, clinical
operation, and data management etc.
Medical Science and Clinical Operation
Clinical and scientific expertise to the clinical trial protocol development process, medical support from IND to NDA strategy for our client product MMP/SMP development.
Medical support for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, medical data review planning.
Provide medical review for AE coding, lab data, medical history, concomitant medications etc.
Medical assessment of subject eligibility.
Support clinical operation team in medical query, emergency etc.
Review of protocol deviations & conduction consistency in medical compliance of the protocol Medical training of TA, protocol, and other medical relative topics etc.
Participate SRC and IDMC activities.
Medical support for regulatory activities such as IND and NDA/BLA submission, regulatory discussion etc.
Pharmacovigilance and Data Management
Responsible for medical review of serious adverse events and non-serious adverse event in support of drug safety activities for clients.
Medical review of assigned cases to include review of narrative, coding (e.g. MedDRA) and accurate assessment of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious).
Perform weekly review of non-serious line listings for potential upgrades to serious and provide medical guidance to triage staff.
Write medical query and similar event analysis and provide causality assessment for individual case.
Review of aggregated reports (e.g. patient profiles, line listings, IND Annual Safety
Reports, DSUR and RMP) in terms of product safety profile.
Provide assessment of safety issues arising in clinical trials and escalate those to the line manager within the organization or/and client.
Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project.
Review and provide input to the Project Specific Procedures and participate in project related meetings.
Communicate with the client to an extent as described in the Project Specific Procedures.
Provide assistance in the preparation and conduct of coding convention.
Potentially, provide support to the site support (call), including provision of the Product related information to the callers as well as review and assessment of reported
adverse reactions.
Involve in the SAE reconciliation between the clinical database and the safety database
Lead the IDMC review and signal detection analysis.
Management Responsibilities
Lead department to identify Medical Monitor/ Medical safety assessment process needs and areas for improvement.
Lead in the development of department or cross functional SOPs, policies and working guidelines.
Manager employee associated with MM/Safety Physician, assign and coordinate projects within the department.
Be responsible for the internal training courses related to MM/Safety Physician.
Provide on-job training to MM/Safety Physician.
Participate in and support business development activities.
Pay and Benefits
The pay range for this position is $250000.00 - $300000.00
Comprehensive benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you'll have access to an Employee Assistance Program to support you in work and life.
Workplace Type
This is a fully remote position.
Application Deadline
This position will be accepting applications until Jan 20, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $250,000 - $300,000
