Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science’s 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In June 2022, we were listed as one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in New York, New Jersey, and Connecticut.

Overview

Assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Works with global cross‐functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc.
• Provides operational support for the Clinical Operations team with heavy focus on study start‐up activities, patient recruitment efforts, maintenance, and study closure deliverables.
• Participates in the creation and distribution of study materials, including essential documents, presentations, and reports.
• Assists with the tracking and documenting of site and sponsor training (e.g., study specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team.
• Actively participates in clinical study team and vendor meetings. Schedules meetings, drafts and finalizes meeting agendas and action items. During clinical study team meetings, provides updates on health and currency of study TMF, and document tracking and currency, tracks and maintains cohesive list of protocol deviations.
• Reviews CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials. Provides crossfunctional support for inspection readiness preparations. Helps coordinate the retrieval of documents and coordination of other activities, as necessary.
• Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure level of detail and adherence to study’s RACT tool.
• Responsible for the QC activities of the Sponsor‐ and CRO‐supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
• Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master File.
• Follows up with CROs, and/or functional area representatives on pending/outstanding documentation in accordance with TMF metrics.
• Assists in preparing TMF Health Reports and collecting TMF status updates and TMF metrics.
• Participates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor agreements. Assists in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.
• Assists with the training and mentoring of newly hired CTAs, as appropriate.

Qualifications

About You:

• Bachelor’s degree in the life sciences, healthcare, and/or related field is required.
• Minimum of 3 years of progressive experience in a Clinical Operations role. Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic Research Organization (ARO), Contract Research Organization (CRO), etc.
• Experience in rare disease and/or orphan indications is preferred.
• Demonstrated knowledge of budgetary and financial practices including review and tracking of budget and forecast, opening and tracking activities of purchase orders, payment tracking and process for external parties.
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and local regulatory requirements, etc.
• Proven experience with TMF, both paper and electronic (eTMF) preferred, including Veeva.
• Solid understanding of the DIA TMF Reference Model.
• Strong familiarity with study start‐up activities, including feasibility, country and site activation, patient recruitment efforts.
• Experience with collaborating with CROs and third‐party vendors to ensure successful and quality execution of studies, and builds strong working relationships to create strong team alliances.
• Applies clear and consistent performance standards, and handles problems decisively and objectively with quality and detail‐ oriented with high standards.
• Ability to interact with all global cross‐functional team members to coordinate/execute study activities.
• Proactively initiates before asked to assist by colleagues, team members and/or supervisor.
• Demonstrated good communication (verbal and written), conflict management, skills, and highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Demonstrated ability to train and mentor/ new hires and colleagues, as needed.
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies/ Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements

Up to 10% travel, both domestic and/or international, with periods of 50% and more travel.

Additional Information

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.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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.