Job Description:

POSITION SUMMARY:
The Senior Clinical Trials Manager is responsible independently managing multiple clinical trials of moderate
complexity or managing a broader range of activities on large multi-center studies. The Senior Clinical Trials Manager
is expected to address site and vendor related issues, with assistance as needed.
KEY RESPONSIBILITIES:
Advance those of the Clinical Trials Manager to include the following:
Responsible for managing approved trial budget(s)
Develops and oversees study operational plan(s)
Coordinates internal and external clinical development activities of all team members involved in the design and
conduct of assigned clinical trials
Assists with protocol design and strategy and medical issue resolution,
Participates in study data review and assists with patient narrative writing and other data review activities as
assigned.
Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and
clinical study reports
Proactively identifies project risks and resolves with some supervision
Participates in the selection of Investigators and vendors
May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of
team
Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:
In addition to the attributes of a Clinical Trials Manager:
Strong study management track record showing clear proficiency in clinical project management skills.
Solid vendor management skills
Broad understanding of operations including those in related development functions
Demonstrates detailed understanding of clinical protocol , intended study populations as well as solid overall drug
development
Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
Demonstrates ability to lead multi-disciplinary teams
Possesses excellent written and oral communications skills

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Qualification:

EDUCATION AND EXPERIENCE:
M.S. (or equivalent experience) and 4+ years of relevant work experience
B.S. (or equivalent experience) and 6+ years of relevant work experience

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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