Senior Clinical Operations Leader - Any East/West Europe

Homebased - East or West Europe & Ukraine.

Parexel FSP are currently looking for an experienced Senior Clinical Operations Leader to join our expanding team in Europe, this is a critical role which will allow us to continue building on our strong year on year growth whilst providing the best service to our clients.

Position Purpose:

The Senior Clinical Trial Manager position has two primary responsibilities: Execution of the clinical trial including site management functions, and management of staff (indirect) within the clinical study team.

Primary Duties:

• Act as Protocol Lead on large complex clinical trials, including Global Phase 3 trials, or several smaller clinical trials. Serve as the main point of contact for clinical site management and clinical trial site monitoring functions.

• Will assist with the design and review of clinical trial protocols, informed consent, case report forms, (CRFs), Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management, and other relevant groups

• Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan. Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.

• Participate in the identification, evaluation, and selection of clinical trial investigators/sites

• Manage clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc).

• Provide support to field CRAs and may assist in the initiating, monitoring, and coordinating day-to day operations of clinical trial sites.

• Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO).

 • Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.

• Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.

• Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.

• Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies.

• Participate in the preparation and follow-up of in-house and on-site Client sponsored quality audits.

Skills and Education:

Minimum 6 + years’ experience CTM or minimum 8 + years’ experience SNR CTM.

Extensive global or regional clinical trial/study management experience

Oncology TA area experience desirable.

Experience running European or global studies from beginning to end.

Extensive study management/leadership experience including startup, maintenance & close out.

Experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend.

Understands how to work with vendors to accomplish tasks.

Experience of dotted line reporting & leading CRA team functions

Experience of customizing tools for all CRA projects.

About ExecuPharm/Parexel FSP

ExecuPharm is a global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world,

Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.