Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

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.


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
upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Project Manager Program & Perform Mgmt Office F/T Days

University Of California

Posted 3 days ago

VIEW JOBS 1/14/2019 12:00:00 AM 2019-04-14T00:00 UC Title: Principal Admin Analyst II Position Number: 10007484 Reports to: Chief Operating Officer, MC Working Title: Project Manager Cost Center: Program & Perform Mgmt Office (8620) Bargaining Unit: None FLSA: Exempt Job Code: 0731 Date Created: 11/16/2018 Shift: Day Shift Hours: 40.00 Position Summary: In collaboration with UC Irvine Health leadership, staff and other key stakeholders (both internal and external), incumbent plays a key role in the leadership and support of project management for operational enterprise initiatives (e.g. Inpatient Flow, Operating Rooms, Emergency Department, Pharmacy, Support Services, Supply Chain, Ambulatory, etc.). Incumbent independently leads and directs multiple projects and/or programs of medium to large size through all aspects of the project and program life cycle (PLC). Plans, manages and evaluates cross-functional/cross-organizational systems, develop/implement projects with high-risk impact to finance or operational efficiency. Anticipates project or program risks and plans with appropriate action to avoid or mitigate risks to project schedules, budgets, deliverables, quality and staffing. Provides leadership and decision making ability where competing interests and priorities involve the highest levels of management. Incumbent manages day-to-day operational aspects of multiple projects including the scope, charters, project plans, current state analysis, solutions, reporting, facilitation, and coaching. Incumbent is able to use Project Management Body of Knowledge (PMBOK), process and quality improvement methodologies (e.g. lean, six sigma, etc.), as well as internal and external best practices to accomplish organizational goals. Salary Range: Rate Minimum $84,200.00 Maximum $151,500.00 Required Qualifications: Ability to communicate clearly to both clinical and non-clinical audiences including management Ability to establish and maintain effective working relationships across the Health System Ability to maintain a work pace appropriate to the workload Ability to manage risk and ambiguity on a project Ability to prioritize, manage and execute multiple fast-paced technical projects in a high-pressure environment Demonstrates team leadership, motivational skills and good creative problem solving skills Excellent time management and organizational skills Excellent written and verbal communication skills in English Exceptional skills in report writing and making technical presentations Experience at working both independently and in a team-oriented, collaborative environment Experience working in the healthcare industry in administration, strategy, project management, business development, or finance department role Must demonstrate customer service skills appropriate to the job Must possess the skill, knowledge and ability essential to the successful performance of assigned duties Proficient in Microsoft Office (Excel, Word, PowerPoint, MS Project, Visio, etc.) Proven ability to quickly develop credibility with relevant constituencies. Proven skills in managing large and complex projects Results-oriented change agent who is an effective business systems thinker Strong interpersonal and facilitation skills Understanding and experience in the principles and application of process and quality improvement methodologies (e.g. lean, six sigma, change management, etc.) Preferred Qualifications: Certified in Change Management Lean Six Sigma Certification Master's Degree in Business Administration, Health Administration or Public Health Project Management Professional (PMP) or Program Management Professional Certification Physical, Mental & Environmental Demands: To comply with the Rehabilitation Act of 1973 the essential physical, mental and environmental requirements for this job are listed below. These are requirements normally expected to perform regular job duties. Incumbent must be able to successfully perform all of the functions of the job with or without reasonable accommodation. University Of California Irvine CA

Sr.Assoc,Clin. Trial Mgmt

Expired Job