Expert Clinical Manager
For one of our clients, a multinational pharmaceutical company, we are currently looking for a
- Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under the management of the CTH. Assigned responsibilities can include:
- development of specific sections of protocol and related documents
- development of study tools
- guidelines and training materials
- management of clinical study material
- oversight of vendors and other third parties
- implementation of issue resolution plan
- conduct clinical data review.
- Prepare clinical outsourcing specifications. Responsible for management of Contract Research
- Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
- Support the development, management and tracking of trial budget as assigned, working closely with the appropriate partners in Oncology Global Development (OGD and GMA).
- Manage interactions with relevant line functions including Data Management, Drug Supply
- Management and country organizations under the direction of the CTH. Attend Clinical Trial Team (CTT) meetings, participate and report study progress and issues/resolution plan at the Clinical Trial Team meeting.
- Responsible for accuracy of trial information in all trial databases and tracking systems.
- Responsible for the ongoing scientific review and validation of clinical data (member of the
- Data Review Team).
- Participate in the organization and logistics of various trial-related committees.
- Point of contact for managing site-related issues and procedural questions. Support CTH in
- development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data
- review reports and trial statistical analysis.
- Write CTT meeting minutes. May occasionally deputize for the CTH to facilitate CTT meetings.
- May participate in International Clinical Team meetings (ICT). Organize and chair trial sub teams within the scope of his/her delegated responsibilities.
- Prepare training materials and presentations related to the planning and conduct of the trial.
- Contribute to program level activities (e.g., development of clinical sections of regulatory
- documents such as Investigators’ Brochures, DSUR/PSUR, IND/NDA submission documents)
- and provide support, as needed, for HA and/or IRB/IEC inquiries.
- Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within OGD & GMA, including sharing lessons learned.
- Contribute to talent development in OCD through active participation in on-boarding and training activities. Participate in OCD Initiatives and working groups.
Qualifications and Experience:
- Advanced (e.g., Masters) degree or equivalent education / degree in life science/healthcare is strongly recommended.
- Language: Fluent English (oral and written)
- 2 to 5 years of experience in clinical development with a minimum of 2 years in global clinical research.
- Involvement in cross-functional, multicultural and international clinical trial; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
- Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
- Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.
- Proven networking skills and ability to train colleagues.
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
- Basic knowledge of oncology, haematology, endocrinology or any appropriate therapeutic area is Preferable.
- Relevant working/residency permit or Swiss/EU-Citizenship required