Manager Clinical Development

Manager Clinical Development
Company:

Software Guidance & Assistance


Manager Clinical Development

Details of the offer

Location: Madison, NJ
Bill : $122.28 HR

What Your New Manager Wants You To Know:

The Manager, Clinical Development Psychiatry may have global and regional responsibilities of a Clinical Scientist. The Manager, Clinical Development Psychiatry will participate in internal process improvement activities within R&D and Clinical Development.

A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will:
As the Clinical Scientist (CS), support the Clinical Program Lead and Clinical Scientist.
Lead 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.
Be the key Clinical Development contact for the Clinical Trial Team.
Represent Clinical Development as a core team member on the Clinical Trial Team.
Provide a clinical review of study-specific documentation and training materials.
Perform clinical data reviews.
Design eCRF, data capture, listings, review patient profiles to identify and resolve issues.

Assess reported protocol deviations.

Ensure resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team.
Prepare for investigator meetings

Qualifications:
Bachelor's degree required, Advanced science degree (e.g., MS, MD, PharmD, PhD) preferred.
Scientific knowledge and experience in multiple Therapeutic Areas (CNS TA preferred, especially prior Depression, Bipolar Disorder, Schizophrenia clinical trial experience).
Minimum 3 years of relevant experience or equivalent combination of experience and education.
Ability to travel up to 20% of time, including international travel
In this role, we're looking for a leader who will:
Act as an Owner
Be Excellence Focused
Act as an Influencer
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Source: Dice


Area:

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