Clinical Trial Manager
ImaginAb is an emerging immune-oncology imaging company developing a pipeline of novel products that give physicians unprecedented insights into the patient’s health—enabling better patient selection and treatment monitoring for immuno-oncology therapies and other drugs.
Harnessing the specificity of monoclonal antibodies, ImaginAb designs and engineers small, highly targeted proteins known as minibodies that image important molecular targets using standard Positron Emission Tomography (PET).
Our imaging tools help physicians answer important clinical questions, improving the path of care and ultimately helping patients live longer, healthier lives.
ImaginAb’s corporate office is based in Inglewood, California.
POSITION: CLINICAL TRIAL MANAGER
Summary: Reporting to the VP of Operations, the Clinical Trial Manager provides oversight of the CRO’s management of site and monitoring activities. Proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. Provide oversight and management of study vendors, contractors and consultants. Engages with study investigators, vendors and internal/external stakeholders to exchange information and updates on the study progress. Candidates from either a pharmaceutical or CRO background are welcome to apply. Candidates must be available to travel and visit ImaginAb offices and other external sites.
- Serving as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure.
- Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role.
- Managing and driving activities to ensure that enrolments are met.
- Ensuring that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues.
- Working in accordance with applicable health authority regulations and internal standard operating procedures. Where necessary, participating in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role.
- Deliver appropriate training to your study team on a trial-specific basis. Additionally, you will act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.
Required Skills, Education, and Experience:
- Undergraduate degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
- Minimum of 2 years clinical trial management experience in the pharmaceutical industry or as CRO.
- Have a proven record of successful execution of clinical trials on a global study.
- Able to work to key metrics and motivate a regionally-based study team throughout the project lifecycle. Your experience in the set-up and management of third-party vendors, as well as global study start up, will be self-evident.
- Familiarity with phase 1-4 studies would be highly advantageous.
- Demonstrable knowledge of effective project planning, strong financial acumen, along with the flexibility to manage a virtual team will ensure success within this position.
- Previous experience of working with imaging and oncology trial, and data management is preferred.
Position Location and/or Territory and Travel:
- Remote (United States)
- Position may require up to 40% domestic and international travel
Physical and Mental Requirements / Work Environment:
- The mental and physical demands, and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Remaining in a stationary position, often sitting for prolonged periods during modes of transportation, or in an indoor home or office environment.
- Must be able to access and navigate throughout various buildings and airports; must be able to access and navigate vehicles, aircraft, and other modes of transportation.
- Communicating with others to exchange information and perform duties: talking/hearing/writing/typing
- Ability to read materials in paper format and on a computer screen
- Repeating motions that may include the wrists, hands and/or fingers
- Specific vision abilities required by this job include close vision and ability to adjust focus.
- Ability to read, analyze, and interpret general professional journals, technical procedures and governmental regulations.
- Ability to write reports, business correspondence, and procedural materials.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Moderate to occasionally loud noise levels consistent with an office, outdoor, and airport/transportation environment.
Salary and Benefits:
Salary commensurate with experience. ImaginAb offers a generous health benefits subsidy, long-term disability, 401(k), Employee Assistance Plan, tuition reimbursement, and paid holidays and time off.
How to Apply:
If you are interested in exploring this challenging and rewarding opportunity, please submit your cover letter, SALARY REQUIREMENTS, and resume.
The search is being conducted by ImaginAb’s external HR consultants.
All expressions of interest are considered in confidentiality. We thank all applicants who apply, but only those candidates selected for an interview will be contacted. ImaginAb, Inc. is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.