Medical Manager (Biotech) gn

Medical Manager (gn)

1. Act as Medical Manager by assisting project managers in identifying the key risks to data that are critical to the primary objective, and providing medical input into risk mitigation strategies.
2. Developing/updating the Medical Monitoring Plans.
3. Supporting study teams, investigators, and sites with medical expertise.
4. Provide medical input into adverse event handling, including review of cumulative ADR/SAE listings and any other emergent safety information.
5. Review clinical data and the critical parameters of studies.
6. Assist the Senior Project Leader with day-to-day logistics of assigned study-related tasks, including administrative tasks in study coordination.
7. Support trial team activities such as trial documentation management, milestone tracking, and identification, resolution, and escalation of issues.
8. Participate in regular study meetings, organize meetings, and coordinate internal and external communication. Prepare meeting agendas and minutes.
9. Support the Senior Project Leader in supervision of CROs and other third-party vendors.
10. Manage the Trial Master File and conduct Sponsor Quality Control of uploaded documents and updates of trial-related systems (CTMS).
11. Collaborate closely with Medical Affairs, DS Affiliates, and all other functional departments at DS.
12. Support Affiliates during the site selection process.
13. Cooperate with the Senior Project Leader in budget control and forecasting.

Qualifications:

1. You hold a graduate degree as a medical doctor (MD).
2. Pro-active and self-motivated personality.
3. Excellent presentation and communication skills, combined with a strong stakeholder focus.
4. Fluent written and spoken English knowledge.