Address
Form of work
SalaryClinical Trial Associate
Company Overview
Enliven Therapeutics is a biopharmaceutical company focused on discovering and developing small
molecule kinase inhibitors to address existing and emerging unmet needs in oncology. With a
precision oncology approach, our aim is to help people with cancer to not only live longer, but live better.
About the position
The Clinical Trial Associate provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies).
Key responsibilities:
- Assist with managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Demonstrate experience in working on multiple priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines
- Assist in the creation, maintenance, and ongoing quality review of the trial master file (eTMF) to ensure files are properly maintained and up to date, archived and stored under the direction of the Associate Director of Clinical Operations.
- Assist with planning investigator meetings and preparing site training materials
- Tracks action items to ensure timely resolution
- Assist with training internal and external CRAs, CRO team members, and investigative site staff.
- Participate in the preparation of study-specific documentation (e.g., study reference manuals)
- Provide logistical support for the study team, scheduling meetings, distributing agendas, and writing minutes
- Track key study activities using tracking tools
- Maintain eTMF
- Ensure that supportive study supplies, and documents are available (e.g., clinical supplies, IP kits, non-clinical supply materials)
- Other projects when assigned
Qualifications:
- BS/BA in Life Science or related discipline
- 2+ years industry experience in drug development
- Effective team player and strong interpersonal skills
- Attention to detail
- Proficient with word processing, spreadsheet, database, and presentation software and with filing systems.
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity.
- Excellent written and oral communication skills.
- Comfortable in an entrepreneurial organization wherein the environment is fast-paced and challenging.
Position Type:
This is a full-time position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand.
The expected salary range for this is $80,000 - $1000,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.
