Description
We are seeking a Local Clinical Project Manager (Sponsor dedicated) to lead Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The Local Clinical Project Manager may also perform site monitoring as needed to support the flexible capacity model. The successful candidate will be responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Main Responsibilities:
- Has overall responsibility for the study commitments within the country and for timely delivery of data to required quality
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies
- Ensures compliance with Sponsor Procedural Documents, ICH-GCP and local regulations
- Coordinates site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
- Prepares country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level
- Proactively identifies risks and facilitates resolution of complex study problems and issues
Required Skills and Qualifications:
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- At least a year of experience in Clinical Project Management at Local level
- Very good knowledge of Oncology therapeutic area
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
- Excellent understanding of the Clinical Study Process including monitoring
- Excellent project management skills
- Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills
- Very good knowledge of spoken and written Bulgarian and English language
- Good ability to learn and to adapt to work with IT systems
- Ability to travel nationally and internationally as required
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