Expert Clinical Manager

Recruiting for a Clinical Trial Manager who has working experience in Global Clinical Trials.

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 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 subteams within the scope of his/her delegated responsibilities.

Candidate Profile:

- Advanced (eg, 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.
- Basic knowledge of oncology, haematology, endocrinology or any appropriate therapeutic area is preferable.

Please send CVs or call

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