Duties:
1.accountable for the writing of clinical protocols and related documents in collaboration with other clinical departments,
1.lead the clinical trial protocol development process;
2.contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions;
3.obtain approval from internal review boards
4.Participate in development of effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
5.Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings
6. Lead and matrix manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
7.Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department.

8.Forecast trial resources needs, accountable for the development, management and tracking of trial budget working closely with the program operations group.
9.Contribute to the development of clinical sections of regulatory documents like Investigators\' brochures, briefing books, safety updates, submission documents, responses to Health Authorities questions.


Requirements:
1. science/healthcare is required. MD, PhD preferred.

• 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.

• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment

• Experience in developing effective relationships with key investigators.

• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
Onocology experinece is essential