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13 days old

Clinical Study Project Manager

Biotrial, Inc.
Newark, New Jersey

Biotrial, a leading provider of high-quality pharmacology services, is currently recruiting a Clinical Study Project Managerto join its team in theU.S. headquarters in Newark, New Jersey. With over 25 years of experience in providing scientific and medical services in Early Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe. The company’s 60,000 sq. ft., 110-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.

As a Clinical Study Project Manager,you willprovide customer-focused leadership and project oversight. In this position you will facilitate communication among team members, including study monitors, sponsor personnel and the Biotrial Project Team. You will have responsibility for proactively solving issues, and overseeing the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations. You will work in our state-of-the-art Clinical Pharmacology facility in Newark.

Responsibilities:

As a Clinical Study Project Manager, you will manage Clinical Research studies including but not limited to:

  • Managing and coordinating the activities of clinical trials with the Biotrial Project Team.
  • Serving as the main point of contact with sponsors regarding project timelines, updates, needs and emerging issues.
  • Developing study timelines based on protocols.
  • Ensuring project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
  • Leading the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams.
  • Following screening and recruitment activities to ensure timely enrollment in the studies.
  • Organizing Safety Review Meetings with the principal investigator / sub-investigator / medical and scientific affair team members.
  • Monitoring project scope and ensuring deliverables are fulfilled within timelines and budget.
  • Supporting the Biometrics team to ensure completion of Clinical Study Reports.
  • Managing study contracts/budgets, including approval of vendor/site contracts, budgets and invoices. Collaborating with the Accounting Department to ensure billing agrees with pre-established milestones.
  • Ensuring timely interaction with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
  • Organizing sponsors' visit of the Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).

Requirements:

  • Requires a Bachelor's degree (Masters a plus) in life sciences or related field.
  • Minimum 3-5 years of experience in Phase 1 clinical research and knowledge of GCP and FDA regulatory requirements is required.
  • Good understanding of the drug development process.
  • Must have previous experience managing projects and in monitoring clinical studies.
  • Excellent written and verbal communication skills, as well as interpersonal skills.
  • Exceptional time management and conflict resolution skills required.
  • Ability to interact with all levels of management, sponsor and study site personnel.
  • Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
  • CCRC certification preferred.
  • Proficient computer skills in Microsoft Office Suite.
  • Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.

Biotrial 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, genetics, disability, age, veteran status, or any other characteristic protected by law.

Job Type: Full-time

Experience:

  • Phase 1 Clinical Studies: 3 years (Preferred)
  • GCP and FDA Regulations: 1 year (Preferred)
  • Clinical Trials: 3 years (Required)
  • Clinical Research: 3 years (Preferred)

Categories

Posted: 2019-07-02 Expires: 2019-08-01

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Clinical Study Project Manager

Biotrial, Inc.
Newark, New Jersey

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