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Sr. Manager, Clinical Operations 9/16/2017

Santen, Inc. Emeryville, CA

Company
Santen, Inc.
Job Classification
Full Time
Company Ref #
374230
Location
Emeryville, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
579542794

JOB DESCRIPTION

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PRIMARY PURPOSE OF POSITION:

Plays an essential role in the development and implementation of global clinical research projects by managing the global clinical operation activities of assigned studies. The role functions as part of Santen's global clinical research group. Responsibilities include the planning, execution, and interpretation of global clinical trials and data collection activities. Performs managerial functions of moderate to significant scope with a high level of independence.

MAJOR DUTIES OF POSITION:

Develops and maintains close working contacts with other functional areas outside of GCD & MA e.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. at Santen to facilitate clinical trials research.
Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
Writes clinical standard operating procedures and provides training to more junior level clinical operations colleagues.
Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.Suggests courses and seminars to attend to develop professional expertise in all facets of clinical operations.
Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
Interfaces with CRAs; a key contact with clinical sites regarding questions on the clinical protocol requirements, key contact with CRO.
Manages Global Clinical Operations activities working with Clinical Science, Biometrics, Device Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data.
o Prepares/procures of all manner of documents and supplies related to the clinical trial process (e.g. Investigator s Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.)
o Develops the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. IDE s, PMA s Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s).
o Manages Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies.
o Develops monitoring requirements to assure quality monitoring activities.
o Enables negotiations and preparation all legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance).
o Monitors clinical studies to assure they are conducted in compliance with the protocol, Santen Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
Manages global clinical operations activities for assigned projects, including but not limited to, the following:
Execute smaller FDA submissions, like registration, export certificates, Technical File maintenance; interface with internal departments as resource regarding the study.
Maintain clinical study files, organize audits of these files in preparation for BIMO audits, maintain clinical trial documentation, IRB correspondence, FDA correspondence, potentially assist with preparation of scientific abstracts, slide presentations regarding study results,
Responsible for development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
Manage clinical operation activities to meet enrollment targets according to the projected timeline, including being the key contact for external CRO s.
Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.
Develops and maintains close working contacts with other functional areas outside of GCD&MA e.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. at Santen to facilitate clinical trials research.