About Insmed:Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency. Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.About the Role:Responsible for the management and oversight of phase I-IV clinical trials 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, 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.This is an non-supervisory position.
This role oversees vendors and/or contractors
Additional representative responsibilities will include, but not necessarily be limited to, the following: 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 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.
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.
About You: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 a minimal oversight and proactively initiates before asked to assist colleagues and/or manager
Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation
Excellent written and oral communication skills, as well as conflict management, time management and organizational skills.
Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.
Up to 25% travel, both domestic and international required
This role is to be filled outside Colorado.Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.Requisition Number: 2021-3220
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