Head of Clinical Operations
Head of Clinical Operations opportunity has risen with global top 10 pharmaceutical company in Hungary!
• Ensure that clinical studies are performed according to the deadlines and quality standards.
• Collaborate closely with Central European Cluster respect to problems related to local clinical studies.
• Ensure the clinical study information sharing with the Medical and ClinOps structures.
• Establish preferential relations with the stakeholders (Medical community, Regulatory Authorities, etc) in order to obtain accurate information on local specifications and facilitate the implementation of clinical trials in the country.
• Define and manage the optimal organisation of the clinical study unit.
• Organise and document delegation of responsibilities within his/her team and detail task distribution.
• Prepare and control together with the financial controller, the local operating budget.
• Ensure preparation of clinical research activity related financial agreements in line with any existing Global template.
• Identification of anticipated resource requirements.
• Ensure appropriate project allocation on local clinical project management level.
• Ensure that clinical trial progress complies with commitments / schedule, define action plans in case of deviation.
• Ensure Medical Advisors meet feasibility or pre-assessment timelines, with realistic commitments.
• Perform / participate in the recruitment of new team members.
• Set / validate the defined objectives for the members of his/her team evaluate their performance.
• Conduct effective on-going coaching with individuals to help maximize their in-role performance and build their capabilities for the future.
• Ensure that assigned trainings are completed on time by local team members.
• Prepare and submit salary adjustments proposals based on benchmarks and Affiliate adjustment levels.
• Develop / supervise the development of a network of experts to evaluate the country participation in the clinical studies planned in the framework of portfolio product development strategy.
• M.D. / PharmD preferred but other Life Sciences degree is considered
• Demonstrable experience in clinical research and proven track record in management of cross-functional teams
• Thorough knowledge of clinical study design and all aspects of GCP as well as the regulatory environment of clinical trials.
• Fluent in English and Hungarian.
Please click Apply to submit your resume for review or contact Peter Sitte for further details.
Munkavégzés helye: Budapest