Manager, Clinical Trials job Parsippany-Troy Hills New Jersey
Manager, Clinical Trials job Parsippany-Troy Hills New Jersey
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Manager, Clinical Trials Job



Employer Name: SpiderID: 8072285
Location: Parsippany-Troy Hills, New Jersey Date Posted: 10/18/2018
Wage: Negotiable Category: Medical/Health
Job Code: R0007887

Job Description:

Job Title:


Manager, Clinical Trials



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 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopaedics. Ferring's US operations employ approximately 800 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.




Responsibilities:



  • Leadership of Clinical Team (timelines, quality financial oversight, routine meetings)

  • Responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and in compliance with GCP's, SOPs and standards

  • Study Plan development (Safety Monitoring Plan, DSMB Plan, Trial Risk Management Plan, SOP usage, protocol deviation plan) Vendor specifications and oversight

  • Site selection

  • Oversight of DSMB and Steering Committee Activities

  • Audit / inspection Communication and Coordination of CAPA activities

  • Responsible for the coordination of internal/external resources and third parties/vendors for the flawless execution of the study.

  • This role is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. You must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders.

  • Ensure proper documentation availability

  • Ensure proper collection and validation of data and documentation in a timely manner

  • Organize and lead study specific meetings

  • Collect, synthesize and report study information

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

  • Participate in selection and management of vendors, development/follow-up of the associated budget

  • Preparation and oversight of study audits/inspections both internal and external

  • Provide oversight and preparation for FDA pre-approval inspections (PAI)


Requirements:



  • BA or BS degree in Life Science required

  • 7+ years of clinical trial experience

  • At least 5 years clinical trial management experience



Skills:



  • Thorough knowledge of GCP/FDA/ICH regulations required

  • Thorough understanding of clinical research principles and process

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

  • Proficient in MS Excel, Word and PowerPoint.

  • 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

  • Team player and able to work independently

  • Ability to work well under pressure and with tight schedules.

  • Ability to identify critical issues and escalation to leadership when appropriate

  • Critical thinking and problem solving mindset



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



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Future Step Company Type:
Company: Future Step
City:
State:
Zip:

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