Clinical Trial Manager/Development Team Project Coordinator
The Role & Responsibilities of the Clinical Trial Manager/Development Team Project Coordinator at Nimbus
Reporting to the Clinical Medical Officer, the Clinical Trial Manager (CTM) will work with the consultant Clinical Operations Lead on oversight of Nimbus’ clinical trials, ensuring on time and on budget execution, in compliance with SOPs, Regulatory Authorities, and ICH/GCP guidelines. In addition, the CTM will provide support and contribute to IND-related activities.
The CTM will independently execute the following activities with limited oversight:
- Oversees CRO tracking activities beginning from CRO award through trial close-out, including study start-up activities, patient accrual, patient eligibility, protocol deviations/violations, and adverse event reporting
- In collaboration with Clinical Operations Lead, provides oversight to CRO(s) for clinical monitoring from site qualification to site closure visits, ensuring integrity of clinical data with respect to accuracy, accountability, and documentation
- Prepares and/or assists with preparation of study documents (i.e., informed consent, site instructions, study manuals, eCRFs, data review plans, etc.)
- Prepares and/or assists with development of clinical trial protocols, protocol amendments, and administrative letters
- In collaboration with Clinical Operations Lead identifies, selects, and provides oversight of investigative sites for participation in clinical trials
- Assists in planning and conduct of Investigator’s Meetings
- Monitors the status of clinical data collection of assigned clinical studies
- Provides input and coordinates the delivery of clinical trial drug product in collaboration with the clinical supply team
- Drafts, incorporates comments, and finalizes meeting minutes for Clinical Subteam meetings
- Maintains trial master files, in accordance with applicable regulations, industry accepted standards, and SOPs governing clinical studies
- Coordinates generation of data to enable dose escalation decisions, safety evaluations, development of IND annual reports, responses to HA/IRB/EC requests, etc.
- Reviews and tracks site and vendor invoices and payments
- May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors
- May perform periodic visits to sites and/or CROs to assess progress of studies and/or protocol compliance
- Completes administrative tasks throughout all stages of clinical trial execution
- Acts as a project coordinator for the Development Team to support IND-related activities
- Performs other work-related duties as assigned
The Qualifications We Are Seeking
- Bachelor’s Degree in a Health or Science field
- Minimum of 2 years of related experience working in clinical research within a pharmaceutical, biotechnology, CRO and/or healthcare setting
- Knowledge of current regulatory requirements and guidelines governing clinical research
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, project management tools, etc.
- Excellent organizational skills and attention to detail
- Ability to establish priorities, schedule, and meet deadlines
- Must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
- Some travel would be required for site training, meetings and educational seminars
A Snapshot of Nimbus
Nimbus is a ~ 30 person biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our team offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together.