Clinical Research Study Leader (m/w/d)
Posted on Aug 24, 2020 by ITech Consult
Clinical Research Study Leader (m/w/d)- leadership/Life science/global study management/English/clinical trials
For our customer a big pharmaceutical company based in Basel we are looking for a Clinical Research Study Leader
The role of the Clinical Research 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 through 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.
Tasks & Responsibilities
. Leads the cross-functional Study Management Team (SMT). In the SMT Leader (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. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality.
. 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.
. Accountable for all aspects of study management including supply management, bio sample management, vendor selection and management, site selection, 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, 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 life cycle.
. Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.
. Minimum 7 years in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies
. Minimum Bachelor (preference on Master) in Life Sciences educational field
. Experience with global study management
. Experience with early phases of clinical trials
. Effective leadership skills, able to lead cross-functional teams across multiple time zones.
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 CRSL1 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
Reference No.: 919628SGR
Role: Clinical Research Study Leader