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16 Jul 2019

Full-Time Clinical Trial Manager

meg.graham – Posted by meg.graham Anywhere

Job Description

Bedminster, NJ

Job Description

Mallinckrodt Pharmaceuticals, a leader in specialty pharma with a focus on Auto-Immune, Rare Disease, Acute/Critical Care and Regenerative Medicine, is recruiting a Clinical Trial / Senior Clinical Trial Manager – Regenerative Medicine. This position will be located in our Bedminster, NJ headquarters.

Mallinckrodt excels at Managing Complexity and Improving Lives. We focus on the Patient, and improved Patient Outcomes in all that we do. Clinical Trial Managers play a highly important and visible role in this. We are looking for a Clinical Trial Manager to lead internal cross functional teams and manages the relationship with vendors and CROs to ensure successful execution of clinical trials. You will oversee all clinical operational activities (Phases 1-4) with a focus on Phase 2 and above.

Essential Functions Include:

•Develop and coordinate trials and operational activities on time and under budget
•Lead cross functional teams and work with your partners in Medical Science, Regulatory, Data Management, etc.
•Review and contribute to protocols, amendments, CRFs and CSRs as well as develop informed consent documents
•Coordinate the qualification and selection of investigative sites, plan for and present at Investigator Meeting and develop other site training material
•Develop clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution including project, communication, monitoring, recruitment, risk mitigation and contingency plans
•Partner with CSP in identifying appropriate vendors for possible selection
•Manage vendor and CRO activities and track internal and external project deliverables
•Responsible for ensuring the development and updating of cost estimates and the study and project level
•Partner with the CSP team in developing complete clinical trial external cost estimates
•Ensure CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits. Follows up significant project issues at investigative sites
•Ensure study execution compliance with GCP/ICH and any other regulatory project issues at investigative sites
•Develop trial monitoring plan and track /report compliance
•Partner with the Clinical Trial Associate I/II to ensure the TMF is developed
•Stay current with regulation and industry trends
•Actively communicate project issues and identifies risks. Work with drug development partners to resolve project challenges

To Be Successful in this role, you’ll need the following at a Minimum:

•Bachelor’s degree
•FOR CTM – 5 or more years directly related experience required
•FOR SR CTM – 8 years directly related experience at a minimum
•Previous CRO/Vendor Management Experience
•Previous monitoring, study coordination, clinical project management experience
•Global trial experience
•Experience conducing the following: PSVs, SIVs, IMV, and COV
•Ability to travel up to 35%
•PC Skills (MS Office Suite) Communication skills (verbal and written)

Other Nice to Have Experiences:

•Experience with Auto-Immune, Rare Disease, Hospital Based products and/or drug device combinations experience in late stage trials
•Experience in the following: Regenerative Medicine, Burn, Skin, Blood, Vaccine, Stem Cell, Wound Care, Transdermal
•Knowledge of cGCP, ICH, and FDA regulatory requirements
•Solid Project Management and analytical problem solving skills
•BSN/RN or Bachelor’s degree in a science

What we’re offering:

•Mallinckrodt strives to be an employer of choice, offering a robust suite of benefits, flexibility and competitive compensation
•New hires will be covered day 1. No waiting period for benefits
•Competitive base salary and bonus target. Employee Stock Purchase Plan and other ancillary benefits
•Complimentary Coffee/Fruit Smoothie Bar, Health Club, subsidized cafeteria and a fun, “jeans allowed” work environment.

How to Apply

Job Types: Full-Time.

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