Clinical Development Manager

Profile:

Clinical Development Manager - Belgium

The executor of a Global Study Management (GSM) mission will have to participate in the Clinical Development activities for a program or product/franchise within the context of the process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP) and internal standard operating procedures (SOP).

The collaboration will be done with the Director Clinical Development or Lead CDM (Lead Physician).

These activities could be related to a product, a protocol or a study. Drive activities or components of a Clinical Development Plan (CDP) as appropriate:
· Definition of the outline and content of the protocol,
· Establishment and maintainance of liaisons with investigators.
· Completing tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
· Analysis and interpretation of the results
· Supervision of the study conduct
· Assurance that results meet the highest standards of quality
· Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
· Contribution to achieving project goals and effectively influence individuals to accomplish objectives in a matrix team environment.
· Be a scientific/medical reference for the assigned product, protocol or study. Serving as a key knowledge source for internal stakeholders including Country Medical Department staff regarding study data, to be utilized in communication media and in documents for the specific disease area
Education
Master degree in Sciences: MD or PhD.
Knowledge

Proven expertise in clinical research with international good Clinical Practice Guidelines, basic knowledge of experimentation
laws and regulations.

· Starting level of leadership of small teams under stress
· Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results
· Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.
· Excellent knowledge of written & spoken English, knowledge of French is an asset
· Good communication skills
· Team spirit
· Well organized



The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.