Premier Research is looking for a Medical Scientist Lead to join our Medical Affairs team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
ROLE RESPONSIBILITIES:
- Provides all aspects of management supervision to Medical Scientist/Specialist staff, including but not limited to, performance management, review and approval of timesheets and expense reports, and resource management including interviewing, hiring, onboarding, mentoring and providing direction on operational delivery.
- Proactively sets up, documents, and communicates project specific medical scientist/specialist requirements and expectations to support medical monitoring activities for assigned projects.
- Collaborates with Medical Monitors/Directors under medical guidance in the conduct of studies; effectively supports the development and review of medical monitoring and other study related plans, reviews and provides support for site and project team queries, reviews medical data including labs, patient profiles, CRF data, and eligibility/enrollment reviews.
- Ensures compliance with and adherence to all internationally recognized standards (e.g., ICH GCP, ICH E2A, etc.), national regulations and SOPs applicable for specific projects.
- Partners with Medical Monitors/Directors and/or assigns Medical Scientist to support initiation of medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements.
- Tracks study progress, reviews budget and scope of Medical Scientist/Specialist team’s responsibilities, conducts and/or oversees Medical Scientist execution of medical data review and TMF filing, participates in relevant internal and external meetings, assists with clinical issues, reviews and QCs study documentation, proactively resolves issues, and makes recommendations to Medical Monitors/Directors where appropriate.
- Is point of contact and knowledge resource for core Medical Scientist and Medical Specialist activities.
- Proactively researches and evaluates new technology tools to enhance study processes and makes recommendations to support effective implementation.
- Supports preparation for audits and inspections by sponsors or regulatory agencies.
- Participates in relevant corporate initiatives and actions that ensure the continued success of the company (such as technology innovation and integration)
- Other activities as designated.
REQUIREMENTS:
- Advanced degree in medical or scientific field (e.g., PhD, MD).
- 2-4 years of relevant CRO, Pharmaceutical, or Medical industry experience.
- Knowledge of ICH/GCP regulations as well as working knowledge of applicable agency Guidance Documents, Regulations, and Procedures.
- Proficient in Microsoft Word, Excel, and other relevant tools, including web-based communication tools for meetings and other industry related technology platforms.
- Fluent verbal and written in English as well as the local language(s).
- Excellent team player, collaborative and able to build an effective team.
- Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication and negotiation skills.
- Excellent organizational and time-management skills, able to prioritize workload to meet deadlines.
- Is accountable, dependable and demonstrates strong commitment.
- Customer service focused in approach to work both internally and externally.
- Maintains a positive, results oriented work environment.
