Description:
The Associate Manager, Clinical Operations is responsible for supporting operational planning, implementation and conduct of assigned clinical trials in compliance with applicable clinical and regulatory standards. The Associate Manager, Clinical Operations will collaborate across a variety of functional groups including Clinical Development, Biometrics, Regulatory, Clinical Supply Chain, Project Management, Contracts and Finance in support of the execution of clinical trials. This role will work closely with the Gossamer Ireland Clinical Operations team to drive successful study execution and CRO oversight across Europe and ex-US countries.
Essential Duties and Responsibilities
- Assist in the management and execution of phase 2 and 3clinical trials from study start-up to final clinical study report; anticipate problems and propose risk mitigation plans to ensure successful and timely completion of the trials
- Assist in oversight of CRO study conduct to monitor adherence to contractual obligations, scope(s) of work, regulatory requirements, GCP principles
- Assist and track the development of site-level study documents (e.g. reference manuals, Laboratory manuals, CRF Completions Guidelines, forms, etc.)
- Manage site supply inventory (e.g. laboratory kits, ancillary supplies, etc.) as necessary
- Provide oversight of Trial Master Files for one or more assigned clinical programs. Performs and/or oversees routine file audits, including issue resolutions with CRO partners and 3rd party vendors
- Supports the study team in Investigator Meeting planning and execution, as required.
- Supports the study team in the organization and conduct of internal meetings.
- May assist in creation of Request for Proposals (RFPs) and in the selection of CROs and other applicable vendors
- May perform study site visits to provide Sponsor-level support
JOB QUALIFICATIONS
- BA/BS in a relevant scientific discipline required.
- 4+ years of experience in supporting clinical trial management for industry sponsored trials.
- Experience in oversight and management of an eTMF is required.
- Experience as a clinical research monitor is beneficial.
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Solid interpersonal skills and demonstrated ability to lead is required.
- Effective verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint, SharePoint and Excel
- Strong attention to detail and dedication to accurate and high-quality work
- Focus on results, highly collaborative cross functionally, and proactive.
- Effective time management skills and ability to manage competing priorities.
- Domestic and International travel may be necessary (up to 15%)
- This position will be based out of our Dublin, Ireland office and can be Hybrid or Remote.