Clinical Research Study Leader
Posted on Aug 24, 2020 by NextLink Solutions
Are you looking for an interesting and challenging opportunity in Switzerland?
NextLink is looking for a Clinical Research Study Leader to work in Basel, Switzerland for a 12 month contract(possible extension) for a multinational client.
NextLink Solution, a Swiss IT Consultancy Company that has been providing both IT services and IT staffing to major customers for the past 20 years, has an excellent opportunity that can take your career to the next level.
Job title: Clinical Research Study Leader
Location: Basel, Switzerland
Duration: 12 month contract (possible extension)
Deadline to respond: ASAP
Please feel free to pass this information/in mail to anyone you know of who would be a good fit for this role.
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.
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, please ensure your candidates are aware about it. If that helps, we are looking for an experienced GSM or a GSL in terms of level of experience.
On a soft skills point of view, we need someone flexible and able to adapt to changes with excellent communications skills and team spirit.
Must - have skills:
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.
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, 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 life cycle.
Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.