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Sr.Assoc,Clin. Trial Mgmt

Expired Job

Medfocus Irvine , CA 92602

Posted 4 months ago

Sr Clinical Trial Management Associate
Title: Senior Clinical Trial Management Associate
Reports to: Assoc Director/Sr. Mgr./Director, Global Clinical Trial Management
Supervises: Collaboration with other R&D; functions
Position Summary
The Sr Clinical Trial Management Associate assists the Clinical Trial Manager (CTM) or Operations
Study Lead (OSL) in the operational execution of assigned clinical studies. Depending on the
experience of the incumbent, they may be assigned to manage a small study as a Clinical Trial
Manager (CTM).
The employee is expected to be fully capable of performing all the roles encompassed in the
preceding grade levels within the job family as required by the organization. Other activities, special
projects and assignments may be assigned as required. As a result, the percentage of time spent
across key duties listed below for which the employee is responsible for or assisting with will vary.
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.
Key Duties / Responsibilities
Role: Clinical Trial Management Associate Oversight: Minimal oversight
The incumbent supports the CTM/OSL in ensuring the assigned clinical study(ies)
are run to time and budget and are completed in compliance with all
relevant laws, regulations, and regulatory guidelines as well as all Allergan
policies and procedures. The incumbent may also be asked to participate as a
Global Clinical Trial Representative in cross-functional teams such as Case
Report Form Review Team and Clinical Trial Team.
The incumbent assists the CTM/OSL in all aspects of a clinical study(ies) including,
but not limited, to the tasks specified below.
Study Concept, Planning and Strategy Phase
The incumbent is responsible to assist the CTM/OSL and FACT team with regional
study feasibility, the initial assessment of any vendors, supplies planning and the
development of study specific documents and timelines as required.
Study Initiation Phase
The incumbent assists the CTM/OSL in region-specific document development
including the informed consent forms; regional investigator
meetings/presentation of materials; the development of regional enrollment
initiatives; and planning regional clinical study supplies. They assist in obtaining
the required translations, collecting non-essential documents from site and
ensuring sites are trained in collaboration with the site monitor.
Study Management/Conduct Phase
The incumbent assists the CTM/OSL in: regional financial management; database
lock activities; regional study drug management; regional trial master file
management; regional study enrollment management (e.g. contingency plan
execution); periodic review of protocol deviations; regional vendor management;
and ensuring adverse event reporting.

Minimum Requirements:

The Sr ACTM assists the CTM or OSL in the operational execution of assigned clinical studies.

Experience:

In addition to the essential skills, the incumbent must have the following:

  • Ability to handle and prioritize multiple tasks simultaneously,

  • Work effectively in a team/matrix environment,

  • Understand technical, scientific and medical information,

  • Handle conflict management and resolution, and

  • Understand clinical study budgets

  • Plan, organize, project manage and analyze data,

  • Advanced computer skills in Microsoft Office

Qualifications / Experience:

  • B.A/B.S. in science or health-related field

  • Four (4) years clinical research experience or related experience with a Bachelors Degree

  • Monitoring experience is preferred

Please send resume to

  • Min Salary:* $0.00

Max Salary: $0.00

City: Irvine

  • State:* CA
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Sr.Assoc,Clin. Trial Mgmt

Expired Job

Medfocus