Website everly_well Everlywell
Lab Testing Made Easy. Results You Can Understand.
COMPANY
EverlyWell is a consumer-initiated at-home laboratory testing company with easy-to-read and actionable results. We are at the forefront of personalized health, transforming the $25B lab testing industry. We’re here to empower people to take control of their health by making lab testing easy to access, understand, and afford. We seek excellence in everything we do for customers and our teammates.
ROLE SUMMARY
We are hiring a Senior Clinical Trial Manager to support clinical trial operations at Everlywell. This position will be responsible for the operational management of clinical research studies for our internal and external clinical research programs. This individual will oversee the successful day-to-day execution of clinical trials from the protocol concept, CRO and vendor management, through to clinical study reporting and ensuring timely completion of study deliverables.
Reporting directly to the Head of Clinical Science, you will work closely with scientific project leads and study investigators to generate real-world data and clinical evidence for our health and wellness products. This position will require a candidate to work in a fast paced environment, have the ability to work in ambiguity, be proactive in seeking and utilizing the resources available to effectively problem solve, have the ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality, and to be able to identify areas of improvement to drive efficiency within Clinical Operations.
We are in high growth, startup mode and need someone who is willing to get their hands dirty. If you are passionate about clinical operations and looking for an opportunity to learn, build, optimize, and grow in a dynamic digital health environment, EverlyWell is the place for you.
What You’ll Do:
- Manage all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out.
- Prepare, review, and manage study related plans and documents including: Institutional Review Board submissions, protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision.
- Participate in identifying, selecting, and monitoring the performance of clinical sites.
- Provide ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations.
- Participate in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities.
- Identify any potential risks to the study timelines and/or conduct, propose mitigations and implement solutions with cross-functional team and manager support.
- Monitor clinical data entry progress and follow up on incomplete data entry and/or outstanding queries.
- Provide oversight of regional monitors or contract research organizations (CRO).
- Establish and maintain strong relationships and communication with sites and site staff.
- Ensure Trial Master Files (TMF) are current and maintained.
- Provide guidance and mentorship to CRAs (Clinical Research Associates).
- Assist in identification, hiring, and training of appropriate CROs and third party study vendors.
- Reviewing or approving of investigational product (IP) release packages; Manage IP accountability and reconciliation processes.
- Perform clinical data review of data listings and summary tables, including query generation and resolution.
- Work cross functionally with other departments such as Legal, Data Management, laboratory operations, and Finance on all aspects of the clinical trial.
Your Education & Experience:
- Bachelor’s degree or higher in the life sciences or related field required. Additional coursework in clinical trial planning and execution strongly desired.
- Ideal candidate will have at least 5 years of relevant experience in managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution.
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
- Thorough knowledge of GCP, ICH guidelines and other US clinical regulatory requirements.
- Working experience with an electronic data capture system, CTMS system, and eTMF system.
- Strong interpersonal communication (written and verbal), organizational and prioritization skills.
- Able to work effectively under a fast-paced and changing environment.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Proficient with office automation tools, such as Microsoft Office and the Google suite of apps.
We Love Working Here:
- Venture backed by top-tier firms
- The opportunity ahead knows no bounds
- Open vacation policy
- Employee discounts
- Paid parental leave
- Health benefits
- 401(k)
EverlyWell is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.
HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.