Manager, Clinical Development/Clinical Scientist I

회사: Allergan Aesthetics
직업 유형: Full-time

Job Description
Position Summary
As defined in the scope of the assigned development project(s), the Manager, Clinical Development may have global or regional responsibilities and fulfil the following role:
Clinical Scientist (CS)
The Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.
Key Duties
The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the CPL and CSL in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for:
Representing Clinical Development as a core team member on the Clinical Trial Team
Providing a clinical review of study-specific documentation and training materials
Performing clinical data reviews
Assessing reported protocol deviations
Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team
The CS may present the clinical development aspects of a project and clinical trial results at internal or external meetings (e.g., with Regulatory Authorities, meetings with external experts).

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