Expert Clinical Manager

EXPERT CLINICAL MANAGER

RESPONSIBILITIES

- Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
- Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
- Prepare training materials and presentations related to the planning and conduct of the trial.
- Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
- Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations.
- Accountable for accuracy of trial information in all trial databases and tracking systems.
- Support the development, management and tracking of trial budget working closely with the appropriate partners in Oncology department..
- Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.
- Point of contact for managing/answering questions related to trial procedures and patients' eligibility.
- Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings.
- Contribute to program level activities (eg, tracking of Oncology program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
- Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
- Contribute to talent and career development of Oncology staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for Oncology training programs.

REQUIREMENTS

Advanced degree or equivalent education/degree in life

science/healthcare required accompanied with 2

years experience in clinical research

or Bachelor degree or equivalent education/degree in life

science/healthcare required if accompanied with 4

years experience in clinical

LANGUAGES:FLUENT ENGLISH (ORAL AND WRITTEN)

EXPERIENCE:

- Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
- excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
- Proven networking skills and ability to train colleagues.
- Proven ability to work both independently or in a team setting, including a Matrix environment
- Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
- Knowledge of principles for trial budgeting.
- Basic knowledge of oncology and/or haematology preferable.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.