- The Study Manager will be responsible for the operational management and oversight of specific clinical studies within 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
- 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.
Other Qualifications, Skills and Abilities:
- 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).
- Exciting job in a dynamic and entrepreneurial environment with room for personal development
- Employment contract of unlimited duration with a competitive salary package