Clinical Study Manager
- Experience Level
Hobson Prior are looking for an Clinical Study Manager to join a drug discovery and development company who concentrates on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders and cancer. This is a permanent position based in Basel.
Please note that to be considered for this role you must have the right to work in this location.
- Confirm knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with investigators, study site personnel, External Service Providers (ESPs), other external parties and affiliates.
- Lead and manage the cross-functional clinical study team and supervise that the objectives and responsibilities within the team are fulfilled.
- Forecast and manage the clinical study team resources and budget for individual clinical studies.
- Coordinate the clinical study activities with respect to Investigational Medicinal Products e.g., ordering, labelling, distribution and extension of expiry date.
- Organise, contribute to and ensure delivery of key clinical study documents such as clinical study protocols, protocol amendments, case report forms, patient information documents and clinical study reports as well as project management plans.
- Ensure review, approval and archiving of clinical study documents in accordance with Standard Operating Procedures.
- Confirm delivery of all clinical study activities in accordance to agreed timelines, budget and quality, and delegation by the Clinical Program Leader.
- Ensure identification and documentation of risks to the clinical study activities and deliverables.
- Ensure that clinical tracking tools and study contact lists are set-up and maintained throughout the clinical study e.g., the study log and clinicaltrials.gov.
- Ensure that study insurance documentation is valid according to current legislation.
- Identify ESPs for clinical study activities and deliverables together with the clinical study team.
- Define the scope for ESPs, lead and manage appointed ESPs and follow-up on ESP performance.
- Identify change of scope requirements to the ESP contracts.
- Manage ESP contracts, amendments and change orders.
- Coordinate or manage the investigator/site selection process, as applicable, and approve the selection of investigators/sites.
- Any other assigned duties.
- Good influencing skills.
- Excellent problem solving skills.
- Demonstrated ability to lead multi-disciplinary teams including team building, negotiation and conflict resolution.
- Excellent written and oral communication skills in English.
- University degree in Life/Health Sciences.
- A minimum of 5 years' experience of planning, conducting and reporting multicentre, international clinical studies.
- Extensive knowledge of all aspects of the clinical study process.
- Experience of managing ESPs.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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