Randstad Professionals is currently looking for a Clinical Research Study Leader who will be assigned a fantastic role for a major client in the region of Basel.
This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector. The initial assignment will start in July and will last 12 months.
Contract details :
Start Date : 01 / 07 / 2020
Requisition End Date : 30 / 06 / 2021
Aim of the Position :
The role of the Clinical Research Study Leader (CRSL) 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.
Candidate’s best profile
The perfect candidate is someone with solid experience in global study management (on a leading level), ideally with experience of early phases, someone with effective leadership skills still able and happy to do operational work.
Please note that there will be operational work involved.
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.
You will be 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, biosample 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 lifecycle.
Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.
Requirements (Mandatory) :
Minimum 5 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
If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email
I am looking forward to receiving your applications