The Study Manager will be responsible for the operational management and oversight of specific clinical studies within the company’s clinical development program.
The Study Manager will work closely with the Clinical Lead and the CMO to ensure successful completion of all clinical deliverables within the required time frame and budget. This function reports into the Clinical Lead.
Responsibilities and Duties
The Study Manager’s duties shall include, but not be limited to:
- Manage all clinical aspects of study from the protocol concept through the clinical study report;
- Oversee performance of CROs and third party vendors to ensure compliance with study protocol and in accordance with scope of work. Identify areas of concern and escalate to Clinical Lead, CMO and/or CRO as appropriate;
- Ensure studies are carried out according to study protocol, SOPs and ICH/GCP regulations;
- Develop and manage the study budget and maintain it within the agreed goals;
- Establish study milestones;
- Track and report on progress of study (both study deliverables and budget);
- Contribute to preparation of study related materials, such as study protocols, informed consent, case report forms;
- Ensure operational plans are developed, such as recruitment plan, monitoring plan, clinical supplies management, laboratory manual;
- Ensure that reporting of SUSARs is established and maintained during the study;
- Ensure identification and selection of investigational sites. Oversee study fee negotiations;
- Develop an ongoing data review plan to ensure that study objectives are met and determine appropriate action (if needed) in conjunction with study team;
- Develop and maintain good working relationships with investigators and study staff;
- Frequent interaction with the cross-functional internal team and external team(s).
Master degree in bio-medical sciences (or related) or relevant experience in a similar position in the Biotech/Pharma industry.
- A minimum of 2-3 years of experience in managing industry sponsored clinical studies, including management of CRO/external vendors;
- Experience in managing multi-country studies is a plus;
- Experience in oncology studies is preferred.
- Quality minded, rigorous, autonomous and customer oriented;
- Good knowledge of GCP regulations and guidelines;
- Experience with an electronic data capture system;
- Able to motivate the internal and external team to work efficiently;
- Ability to foster teamwork and a collaborative atmosphere;
- Fluent in English;
- Well organized, well-structured, hands-on, result focused;
- Strong management skills;
- Enthusiastic, flexible and able to multitask;
- Ability to set priorities and take initiative;
- Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).
You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.
Select Projects is part of an international full-service Human Resources organization, Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium and Dubai, we provide support to companies who need expercienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.
For a Life Sciences Client in Niel we are looking for a CLINICAL STUDY MANAGER (M/V)