Allergan Senior Clinical Trial Management Associate in Buckinghamshire, United States

Senior Clinical Trial Management Associate

Buckinghamshire, England, United Kingdom at https://agn.referrals.selectminds.com/jobs/5901/other-jobs-matching/location-only

Jul 06, 2018Post Date

180737Requisition #

The Senior 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. This role is based in Marlow with minimal requirement to travel.

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.

Key Responsibilities:

  • Responsibility to assist theCTM/OSL and FACT team with regional study feasibility, the initial assessmentof any vendors, supplies planning and the development of study specificdocuments and timelines as required.

  • Assist the CTM/OSL inregion-specific document development including the informed consent forms;regional investigator meetings/presentation of materials; the development ofregional enrollment initiatives; and planning regional clinical study supplies.They assist in obtaining the required translations, collecting non-essentialdocuments from site and ensuring sites are trained in collaboration with thesite monitor.

  • Assist the CTM/OSL in: regionalfinancial management; database lock activities; regional study drug management;regional trial master file management; regional study enrollment management(e.g. contingency plan execution); ongoing review of protocol deviations;regional vendor management; and ensuring adverse event reporting.

  • Support database lockactivities; ensuring all regional documents are filed in the TMF appropriately;ensuring all close-out activities are completed; ensuring study documentationis properly archived when the study is considered completed.

Qualifications

  • Sciencedegree preferably in science or health-related field

  • Previousexperience of working on clinical studies

  • Oversightor mentoring of more junior study monitors (direct or indirect) preferred

Experience:

  • In addition to the essentialskills, the incumbent must have the ability to:

  • Handle and prioritize multipletasks simultaneously,

  • Work effectively in ateam/matrix environment,

  • Understand technical,scientific and medical information,

  • Handle conflict management andresolution,

  • Understand clinical studybudgets,

  • Plan, organise, project manageand analyse data, and demonstrate full competency in Microsoft Office programs.

  • The successful candidate musthave a good understanding of the following:

  • Good Clinical Practices, ICHguidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA andpatient privacy laws (plus applicable local regulations, when country-based),

  • Knowledge of concepts ofclinical research and drug development, and

  • General therapeutic areaeducation and training

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Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.