Clinical Trial Manager

Insmed Inc. • Bridgewater, NJ • 6h ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key trial management support to the Associate Directors (CST Leads), as assigned.What You'll Do: Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines. Detailed management and oversight of regional trial activities, as assigned. Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters. Effectively manages and/or assists with cross-functional clinical study team and team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning. Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff. Manages global monitoring oversight of site-level activities related to ongoing and planned trials Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management. Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders. Provides coaching/mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies. Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings. Proactively identifies potential resource needs to management. Participates in the development and review of department SOPs and process improvement initiatives.Qualifications: Bachelor's degree in the life sciences, healthcare, or related field. Minimum of 5+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution. Experience in rare disease and/or orphan indications is preferred. Experience managing large and/or complex studies and project teams is preferred. Experience in rare disease and/or orphan indications is preferred. Demonstrated experience managing CROs and other specialty vendors is essential. Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations. Demonstrated strong leadership skills and the ability to work successfully in matrixed team environment. Can work independently with limited oversight and proactively initiates before asked to assist colleagues and/or manager * Possess critical thinking skills for problem-solving, co

Go to Apply

Adult Personal Care- Certified Home Health Aide (CHHA) Hourly

BAYADA Home Health Care • East Orange, NJ • 18h ago

Hospital & Medical

Base Pay: $18 - $19/ hour Daytime and Evening Shifts available FULL TIME & PART TIME PPE is provided for all cases Work in your neighborhood and give back to your community. BAYADA Home Health Care has an immediate n...

18h ago

Go to Apply

Physical Therapist (part-time)

HealthFitness • East Hanover, NJ • 19h ago

Hospital & Medical

HealthFitness, a Trustmark company, is a proven leader in providing fitness solutions that engage and connect people both on-site and online, to create a strong community of health. Our work focuses on creating meaningfu...

19h ago

Go to Apply

Physical Therapy Assistant (part-time)

HealthFitness • East Hanover, NJ • 19h ago

Hospital & Medical

19h ago

Go to Apply

Medical Instrument Technician (Polysomnography)

Veterans Affairs, Veterans Health Administration • East Orange, NJ • 22h ago

Hospital & Medical

Summary This Medical Instrument Technician (Polysomnography) position is in Specialty Care services at at the VA New Jersey Health Care System. The MIT operates, and monitors computerized, and other equipment in the Slee...

22h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.