Associate Director Clinical Operations
Vor 5 Tagen
Hobson Prior are in search for an Associate Director Clinical Operations to join a fantastic pharmaceutical company on a permanent basis with the ability to work remotely. Our client is focused on supplying patients with important medicines.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- In this role, you will be responsible for contributing to the development of team and resourcing planning.
- You will be supporting program management with supportable and clear timeline projections and reprojections.
- Responsible for overseeing recruitment plans and activities to meet study enrolment goals and timelines.
- For this role, you will be responsible for leading the Switzerland based clinical operations team (CTMs, CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and completion of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines.
- Contributes expertise in all operational activities relating to the execution of clinical trials.
- Interacts and develops relationships with key opinion leaders, potential/selected investigators, and other key experts through attendance at therapeutic conferences and study investigator meetings.
- Participates in the selection and oversight of Contract Research Organisations (CROs) and vendors.
- Ensures completion of all study-related materials and systems according to timelines and standards.
- Provides input on the development of eCRF design.
- Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting.
- Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments; completes accruals on a regular basis.
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner.
- Any other assigned duties.
**Requirements**:
- A Bachelor's degree in a Scientific related discipline.
- At least 8+ years of relevant and progressive clinical trial management experience.
- Required to travel up to 25%.
- Experience in full-cycle drug development.
- Advanced understanding of clinical trials processes, protocols and medical terminology.
- Advanced experience utilizing CTMS, EDC, TMS and related software.
- Prior experience in management and monitoring of CRO and investigative sites.
- Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management.
- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations.
- Strong experience with bio-samples, storage of 3rd party data.
- Motivated to work in a fast-paced, high accountability environment.
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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