Description
Hameda at Michael Bailey Associates is currently working with a biopharmaceutical company that are seeking a Clinical Trial Manager to join them on a Permanent basis in Basel You will be accountable for leading, planning, implementing and delivering large international Phase III clinical trials in Oncology and onco-hematology & rare diseases.Job Responsibilities:
You will be accountable to manage the initiation, coordination, implementation, and management of large international Phase III clinical trials from the start-up to closeout.
Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
You will lead the cross-functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
Manage operational and technical aspects of projects including budgeting, study initiation, and risk management.
Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
Select, manage and coordinate external vendors, such as Contract Research Organizations, central laboratories, etc.
You will represent clinical operations on multi-function project teams internally and externally; report on study progress.
Monitor vendor and CRO's performance and ensure continuous oversight.
Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans;
You will ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company's specific SOPs.
Key Skills:
Strong project management and negotiation skills.
Excellent budgeting, planning, and communication skills.
Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency.
Ability to lead and influence a cross-functional study team and external partners.
Strong scientific knowledge and involvement.
A high degree of initiative and ability to work independently.
Requirements:
University degree or equivalent in Life Sciences.
Fluent in English - French / German and another European language are an asset.
Large scale experience is critical.
Oncology experience is desirable.
Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO.
Previous monitoring experience preferred.
Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
Experience in management of CROs, vendors and consultants.
Experience in contributing to protocols and clinical development plans
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.