The role of the CR Study Leader is to provide leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man thru Proof of Concept studies. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.
Job Primary Responsibilities and Accountabilities:
Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL 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
- Prepares and manages 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
- Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.
- With SMT partners, ensures 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.
- Conducts protocol and site feasibility assessments to ensure optimal site selection
- 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
- Proactive management of all aspects of the study
- Manages both internal and external partners
- For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study
- Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
- Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
- Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
- Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
- CRSLII may provide support and mentoring to other CRSLs
- Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team.
Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline
Study management experience in clinical or pharmaceutical development.
Working knowledge of international regulatory and ICH GCP guidelines.
Experience, Skills, Knowledge:
CRSL II will be required to have extensive experience leading Phase I and Phase II studies. In addition, experience in Phase II specific to more than one therapeutic area is preferred. It is anticipated that this experience and skill set would have been developed leading clinical studies in pharma and/or biotech over the course of at least ten years. A Study Leader designated as CRSLII would be required to have the skills necessary to lead the most complex studies in the portfolio. Throughout the course of a study, the CRSLII may have mentoring responsibilities for CR SL1 temporarily assigned to assist with complex programs, therefore prior management or mentoring responsibilities is preferred.
The CRSLI candidates will be required to have a skill set that has been developed through leadership of a significant number of studies in pharma and/or biotech. CRSLI candidates will have experience in Phase I or Phase II studies, but are not required to have specific therapeutic area experience. In addition to leading less complex studies, CRSLI employees will develop their skill sets by assisting more senior Study Leaders in the execution of complex studies.
All Study Leaders will be required to have:
- Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies)
- Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members..
- Capability representing the Study Management Group at Clinical Teams.
- Highly developed interpersonal skills and demonstrated business awareness
- Effective leadership skill to lead cross-functional teams across multiple time zones,
- Highly effective verbal and written communication/presentation skills in English
- Effective team work and interpersonal skills (globally, internally and externally) including coaching and mentoring
- Critical reasoning skills including the identification and resolution of complex problems
- Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual
- Direct experience overseeing multiple vendors and sites
- Global experience preferred