Steve Lord is recruiting for a Clinical Research Study Leader in early phase studies to join a leading pharmaceutical company at their site based in Welwyn Garden City on either a permanent or contract basis (6 months initially).
The Study Leader will provide leadership for one or more global study management teams, responsible for internally managed and outsourced studies - first in man through to proof of concept.
The main purpose of the role will be to:
- Lead the cross-functional Study Management Team (SMT). In the SMTL role, the SL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting.
- Prepare and manage 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.
- Identify key milestones and track critical study activities, issues and strategic priorities. Provide regular updates as appropriate, to key stakeholders.
- With SMT partners, ensure 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.
- Conduct protocol and site feasibility assessments to ensure optimal site selection
- Be accountable for all aspects of study management including supply management, biosample 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.
- For outsourced studies, contribute to CRO selection activities and contract set-up, serve as primary contact with CRO PM and provide oversight of CRO, ensure communication between CRO, and other vendors.
- Work with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality.
- Ensure that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelors (or Masters) degree or equivalent in biomedical or life sciences discipline.
- Extensive Study Management experience in clinical or pharmaceutical development.
- Working knowledge of international regulatory and ICH GCP guidelines.
- Extensive experience leading Phase I & Phase II studies in Oncology.
- Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (preference in early phase studies).
- Effective leadership skill to lead cross functional teams across multiple time zones.
- Effective team work and interpersonal skills (globally, internally and externally) including coaching and mentoring.
- Global experience is preferred.
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 Group 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 45559 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephen Lord
- Phone: 01246 457722
- Reference: 45559
- Posted: 17th May 2019
- Expires: 14th June 2019