Senior Clinical Trial Manager

Ferring Pharmaceuticals, Inc. Parsippany , NJ 07054

Posted 2 weeks ago

Job Title:

Senior Clinical Trial Manager

Job Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 6,000 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive medicine (infertility), urology, gastroenterology, endocrinology, maternal health (obstetrics/gynecology), orthopaedics and Oncology. Ferring's US operations employ approximately 900 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:

The purpose of this position is to lead the Clinical Trial Team(s) in the execution of high-quality trials within approved budgets and timelines.

This is an in-house position in Parsippany, New Jersey.

Responsibilities:

  • Leadership of cross-functional Clinical Trial Team(s)

  • Manage study timelines and budget

  • Responsible for all operational aspects of clinical trial oversight including the on time study deliverables, within budget, and in compliance with GCPs, SOPs and established standards

  • Develop Study Plans (i.e. Safety Monitoring Plan, DSMB Plan, Risk Management Plan, Recruitment Plan, etc.)

  • Strong Vendor Management skills

  • Strong understanding of Inspection Readiness and TMF management

  • Oversight of CRO (selection, Scope of Work development, payments, etc.)

  • Oversight of DSMB and Steering Committee Activities

  • Ability to communicate effectively with internal and external stakeholders

  • Provide mentorship to junior level study team members

  • Estimated less than 10% travel

  • Collaborate with the Clinical Trial Supplies to validate Investigational Medicine Products (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process

  • Contribute to departmental process improvement initiatives

Requirements:

  • BA or BS degree in Life Sciences preferred

  • 8+ years of industry experience preferred

  • Demonstrate increasing levels of trial management responsibilities

  • Thorough knowledge of GCP/FDA/ICH regulations required

  • Thorough understanding of clinical research principles and processes

  • Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight required

  • Proficient in Microsoft Office

  • Experience with data collection processes, data review and comfort with using technology including analytics tools

  • Excellent organizational and time-management skills

  • Strong interpersonal skills.

  • Effective verbal and written communication skills including presentation skills

  • Strong project management skills

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com

Location:

Parsippany


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Senior Clinical Trial Manager

Ferring Pharmaceuticals, Inc.