Director, Clinical Trial Operations, Europe

Role Summary

The Director, Clinical Trial Operations, Europe, is responsible for managing the execution of clinical studies and data collection within the European Union and the UK. The incumbent will serve as a regional clinical study lead who oversees the review, monitoring, and adherence to clinical protocols, as well as fulfilling activities related to study completion. The Director, Clinical Trial Operations, Europe, will interact with other regional study leads to facilitate streamlined and quality study execution. They will also work internally and externally with members of the cross-functional study team.

Responsibilities

• Provide oversight of clinical research studies for the EU and UK region.
• Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Oversee all regional vendors and activities, including CROs.
• Oversee regional start up activities including site selection, enrollment projections, and activities driving site activation.
• Develop region specific the subject recruitment/retention strategy and related initiatives.
• Oversight of regional TMF ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities.
• Develop training materials for study team, investigational sites, and vendors.
• Manage information sharing proactively with key stakeholders using standardized reports and other mechanisms.
• Assure clinical studies are compliant with GDPR, ICH/GCP, and other regulations as appropriate. Outline regional activation hurdles for team.
• Participate in RFP development and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities.
• Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed.
• Act as liaison with Regulatory Affairs to assure adherence to GDPR, GCPs; maintenance of SOPs; and site and CRO/vendor audits are completed.
• Perform regional risk management and implement mitigations.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs degree required, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.
• Minimum of 12 years of prior clinical operations experience preferably with CRO/small biotech experience and 8 years of experience in a supervisory role.
• Strong computer skills, including proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems.
• Excellent understanding of drug development process.
• Experience in clinical trial supply management.
• Ability to make appropriate decisions to move the project(s) forward.
• Effective verbal and written communication skills.
• Comprehensive understanding of data flow from sites to data processing, review, and resolution.
• Extensive experience in analysis and report generation.
• Knowledge of EMA regulatory requirements (i.e. GDPR).
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Intimate knowledge of study initiation procedures.
• Ability to exercise judgment and determine appropriate action.

Skills

• Clinical operations leadership
• Vendor and CRO management
• GDPR/ICH-GCP compliance
• Regulatory affairs liaison
• Risk management and problem solving
• Contract negotiation and study contracting

Education

• Bachelor‚Äôs degree in a scientific discipline or equivalent experience

Additional Requirements

• Travel up to 75% of time