TSRI Life Sciences Careers

TSRI Life Sciences is seeking a talented, motivated and team-oriented Clinical Data Manager.

JOB SCOPE

The qualified applicant will possess the following skills:

Write and or review Data Management Plans and other key study documents.
Create, review and process Data Clarification Forms and updates that databases.
Manage the clinical data management process from simple or complex studies.
Liaise with clients and produces study progress reports.
Perform other miscellaneous activities as required.

RESPONSIBILITIES

Additional responsibilities associated with this position are as follows:

B.A./B.S. Degree in related field or an appropriate combination of relevant education and experience.
3-4 years experience in Clinical Data Management.
Experience in Database lock, EDC.
Thorough understanding of clinical trial methodology, ICH, GCP and medical terminology.
Possesses excellent interpersonal and communication skills (written and verbal).
Good project management, organizational and computer skills.

	REGULATORY SUBMISSION MANAGER - EAST COAST Excellent opportunity for experienced candidate knowledgeable with eCTD publishing. Advanced technology experience is a plus. Seeking candidates with a minimum of 5 years+ experience.

	SUBMISSION SPECIALIST - MIDWEST & WEST COAST Seeking experienced candidate for publishing clinical and non-clinical regulatory submission documents in eCTD format.

	CLINICAL DATA MANAGER - EAST COAST Thorough understanding of clinical trial methodology, ICH, GCP, and medical terminology.

	DRUG SAFETY SPECIALIST Seeking experienced candidate with knowledge of U.S. and non-U.S. regulatory requirements.

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