Clinical Operations Specialist
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The Clinical Operations Specialist will work cross functionally with the Clinical Development, Quality, Regulatory, Project Management teams, as well as independently, to plan, implement, and maintain data as it relates to clinical trials. Additionally, this role will partner with external vendors and agencies during all programs including exploratory and clinical phases. This role requires an elevated attention to detail and enhanced organizational skills to track the progress of multiple trials in varying stages.
This position reports to the Executive Director, Clinical Operations in New Haven, CT. This role may be performed remotely from a location in the US.
Key responsibilities of this role include, but are not limited to:
- Assists the clinical operations team responsible in the planning, implementation, and compliance of multiple aspects of Arvinas clinical trials using multiple vendors.
- Provides oversight in clinical trial site level management by reviewing monitoring reports for proper resolution of outstanding action items from start-up through closeout.
- Ensures the quality of the trial master file (TMF) through content review (QC) of documents entered into the TMF.
- Assists the project management in tracking exploratory program activities
- Responsible for accurate capture of meeting minutes and action items of various meetings
- Assists in QC review of documents intended for regulatory submissions
- Participate and lead in internal initiatives as requested
- Seeks opportunities to accomplish new and different requests across Develop Operations function
- Serves as PRS administrator for Arvinas to ensure completeness and accuracy of information submitted to ClinicalTrials.gov
- Familiarity with various CTMS systems
- Various activities to support Clinical Trials as required
- Manage and update Patient Recruitment Trackers
- Manage Sharepoint and Veeva access requests and departmental internal files/folders
- 5+ years of strong hands-on experience supporting all clinical trials execution.
- Ability to coordinate and drive high quality execution across Development Operations.
- Oncology/rare disease experience preferred or multi-therapeutic clinical operations experience
- Ability to build and foster strong relationships with external partners, CROs, and vendors.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Effective communication and interpersonal skills; effective interaction with cross functional team members.
- Proficiency with Microsoft Office Systems.
- Bachelor’s degree in Life Sciences or equivalent work experience.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer