Full Job Description
Immunovant is a clinical stage biopharmaceutical company committed to developing innovative therapies for autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for several indications.
Immunovant is seeking a Clinical Trial Manager to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for supporting the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations team.
Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations.
In collaboration with Sr. Director Clinical Operations, develop study operational strategies including vendor outsourcing approach.
Assist with management of CROs and third-party vendors in line with study and program goals; including reporting metrics
Review of study plans and documents to ensure compliance with GCPs, vendor and in-house procedures.
Participate in site initiation visits
Participate in co-monitoring visits with the CRO
Assist clinical sites with questions and resolving queries.
Ensure complete and inspection ready eTMFs throughout the duration of clinical trials
Support management of study level budgets.
Support development and follow through of effective clinical and safety data review plans throughout the study; as well as supporting development and implementation of corrective action plans to ensure good data quality.
With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team and manage vendors to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans.
Create and improve upon business processes ensure Immunovant’s successful growth
BA/BS in a clinical or scientific discipline; at least 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company)
Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.
Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
Deep understanding of clinical trial operations and management of clinical trials at investigator sites
Multitasking ability to oversee a large number of projects and reach milestones on time
Exceptional academic and professional accomplishments, indicating critical thinking ability
Strong written and oral communication skills with incredible attention to detail
Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
Ability to think outside of the box and challenge the status quo
Natural entrepreneurial spirit with unrelenting dedication to delivering results
Desire to work in a fast-paced, innovative environment
Natural collaborator who enjoys working on a cross-functional team
The position is located at Immunovant’s office 320 W. 37th St., New York, New York
Dynamic, interactive, fast-paced, and entrepreneurial environment
Domestic and international travel is required (up to 50%)