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Clinical Program Study Leader

Switzerland   •  Negotiable  •  Contract/Temporary, Full time


Our leading pharmaceutical company client is looking for a Global Clinical Project Leader.


Background:
The role of the Global Clinical Project 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 Global Clinical Project Leader is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.

Perfect Candidate:
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.


On a soft skills point of view, we need someone flexible and able to adapt to changes with excellent communications skills and team spirit.

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.
* 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.

Must haves:
* 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.

The experience with early phases is highly valued by the manager and will be preferred. But the HM is willing to consider candidates with little experience in early phases.
The leadership skills is a must have. It will not get any stars because too hard to judge off a CV. But please note that the manager will be evaluating that during interviews.


You MUST be eligible to work in Switzerland. Learn more

  • Agency: Key People
  • Reference: MC24988
  • Posted: 25th September 2020
  • Expires: 23rd October 2020

Key People

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