Senior Clinical Trial Manager
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.
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.
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
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 email@example.com
Ferring Pharmaceuticals, Inc.