Clinical Research Study Leader in Welwyn Garden City
Steve Lord is recruiting for a Clinical Research Study Leader to join a leading Pharmaceutical company based in Welwyn Garden City, Hertfordshire, on a full time contract basis for 6 months.
As a Clinical Research Study Leader, you will be responsible for one or more global Study Management Teams responsible for delivering in-sourced and outsourced First in Man through to POC studies.
Further responsibilities of this Clinical Research Study Leader position will include:
- Leading the cross-functional Study Management Team (SMT) and have responsibility for the planning, coordination, communication, motivation and direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting.- Preparing and managing the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.
- Identifying key milestones and tracks critical study activities, issues and strategic priorities, and providing regular updates as appropriate, to key stakeholders.
- Ensuring the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives.
- Conducting protocol and site feasibility assessments to ensure optimal site selection.
- Accountability for all aspects of study management including supply management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.
- Proactive management of all aspects of the study.
- For outsourced studies, contribute to CRO selection activities and contract set-up, serving as primary contact with CRO PM and provide oversight of CRO.
As a Clinical Research Study Leader, you will have the following qualifications, skills and experience:
- Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline.
- Proven study management experience in clinical or pharmaceutical development.
- Working knowledge of international regulatory and ICH GCP guidelines.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
For more information or to apply for this Clinical Research Study Leader position please contact Steve Lord on 01246 457738 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL44070 in all correspondence.