Posted in Other 30+ days ago.
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Type: Full Time
Location: Bedminster, New Jersey
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. This position will be located in our new Bedminster, NJ headquarters. Candidates outside a commutable distance to Bedminster requiring remote working arrangements will be considered on a case by case basis.
Mallinckrodt excels at Managing Complexity and Improving Lives. We focus on the Patient, and improved Patient Outcomes in all that we do. Clinical Trial Manager plays a highly important and visible role in this. We are looking for Clinical Trial Manager (s) 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
* Knowledge of cGCP, ICH, and FDA regulatory requirements
* 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
* 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.
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.