Clinical Manager

For our client in Basel we are looking for a Clinical Manager for a one year contract.
Place: Basel
Period: ASAP- 05.05.2018
Workload: 100%

Responsibilities:
- 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 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 subteams 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 (eg, 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 OGDdemonstrated 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.

For more information, please contact:
Anna Chmura (see below)