Clinical Scientist 9/14/2016
JOB DESCRIPTIONAPPLY 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. This position is based at our Bridgewater, NJ headquarters facility.
The Clinical Research Scientist (CRS) will support the Senior CRS and Medical Monitor for assigned protocols, partnering with vendors and cross functional teams. The CRS will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs).
Participate in cross functional teams to develop and implement Clinical Study protocols within clinical program(s). Responsibilities include but are not limited to:
Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents
Contribute to aspects and stages of the protocol development and execution from study design planning through final reporting of result.
Provide scientific input and review of protocol data, medical monitoring reports, study integrity/conduct and protocol oversight
Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program
Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e. IND submissions, IND Annual Updates, DSUR, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocol
Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Provide scientific support to the study teams, including:
Collaborate with team members in the review and development of Data Management activities including development of eCRFs, edit checks, report development and database lock processes
Participate in activities related to review of data review, database lock, medical monitoring and query resolution for the protocol
Work with medical monitors and drug safety vendor(s) to provide support and scientific review of adverse events
Provide scientific review of statistical analysis plans
Support corporate objectives:
Development, review and revision of departmental and corporate SOPs and processes
Provide clinical development and technical expertise in support of due diligence activities
Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities