Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
Responsible for the direct management and oversight of data management activities for assigned studies. Work in conjunction with the study team to ensure data review, project support, study document management and CRO oversight of; DM timelines, EDC/IWRS set up, study databasedesign, clinical data capture, discrepancy management, and data reconciliation.
- Primary point of contact between CRO and vendors related to the management and oversight of data management activities
- Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization
- Manage and oversee data management related activities with CROs and other external vendors
- Work with vendor(s), particularly to support the DM tasks such as transfer of data, review of data mapping/data conversion plan, review of SDTM datasets etc.
- Manage design and development of eCRFs, including full UAT
- Oversee and manage the development and implementation of edit check specifications and work with CRO during programming & validation
- Participate in data reviews with clinical team to ensure accuracy, consistency and reliability of data
- Work with CROs and study teams to ensure study databases are locked based on pre-defined criteria and timelines
- Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner.
- Provide high quality services through efficient and compliant processes
- Minimum five years of clinical data management experience in a biotech, pharmaceutical or CRO environment
- Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities
- Hands on experience with Electronic Data Capture systems required (Medidata Rave desired)
- Experience in CRO and vendor management required
- Experience with multiple phases of clinical development
- Excellent communication skills and ability to work in a cross-functional team environment
- Strong collaboration skills regarding external and internal teams
- Highly detailed oriented with strong prioritization skills