Project Manager – Clinical Trial

Function: Provide senior-level operational leadership for the project management (PM) team.

Primary Responsibilities:

· Provide operational leadership for Project Managers (PMs)team working on clinical trials

o Work closely with the PMs during the set-up of a project, to ensure compliance with company principles and processes

o Review key study documents prepared by the PM, such as charters and policies

o Review study budgets and contracts

o Prioritize PM tasks, set timelines and monitor progress

o Help resolve specific trial-related or other operational project issues

o Provide close guidance for « sensitive » issues, e.g., timely identifying signs of problems, help addressing them, or escalate as needed.

o Provide guidance for PMs—coordinated meeting preparation and follow-up

o Participate in internal team meetings

o Serve as a senior level operational contact for multiple study partners, including academic collaborative research groups, the bio-pharmaceutical industry, and a variety of vendors, participating in meetings, and supporting PMs in preparing, and following- up as necessary

· Perform PM tasks for specific studies / projects, if needed

· Serve as line manager and direct supervisor for individual PMs

o Train / coach PMs on client guidelines, policies and SOPs

o Participate in professional development discussions, setting objectives and training plans with PMs

· Motivate and guide members of the PM team under their supervision to learn, interpret and apply a variety of complex policies and procedures with minimal guidance

· Inspire team-work

· Communicate effectively in multicultural teams within company Headquarters and the company network, and across organizational boundaries, respecting differences between people from a variety of linguistic and cultural backgrounds

· Maintain a high level of poise and professionalism while coordinating a diverse variety of daily and special project deadlines simultaneously

· Work closely with other PMLs, to identify and resolve common PM and trial operational issues to be discussed during recurring the operational team meetings

· Identify areas of improvement in company HQ operations and contribute to its continuous optimization (e.g., development of new procedures, tools, etc.)

· Participate in initiatives aimed at harmonizing or improving the efficiency of interactions between company HQ and company member groups

· Develop training modules for PMs on a need basis, in collaboration with the other PMLs and Research Operations Director (ROD)

· Support ROD as needed

Qualifications sought:

· Academic degree, preferably in a (para)medical discipline

· Sound knowledge of GCP and methodologies, regulations and procedures related to clinical trials

· Experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO)

· Experience in oncology clinical trials is a plus

· Previous experience in managing budgets and contracts is a plus.

· Strong analytical skills and highly organized project management abilities, sense of diplomacy, and attention to details, while maintaining a broad overview

· Demonstrated leadership skills and people management experience

· Native or native-like written and spoken English; French, Dutch or other languages are a plus

· A high level of integrity and sense of responsibility and professionalism