Clinical Trial Manager/Sr. CTM, CLINICAL OPERATIONS

Location
Louisville, KY, United States
Posted
Sep 22, 2020
Ref
384886550
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
Talaris Therapeutics, Inc. ("Talaris") is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a "Holy Grail" of organ transplant. In a ground-breaking, phase 2 study conducted between 2009 - 2016, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant, without rejecting their donated organ. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we have a corporate office in Boston, MA

Description of Position

Manages and tracks overall operations of a clinical study including project plans, budget, and resource management. Leads development of study operational plans and is able to provide input into other functional area plans as needed. Provides excellent oversight of the CRO, vendors and sites. Ensures compliance with GCP and regulatory guidelines. Position reports to Director, Clinical Operations.

Principal Duties and Responsibilities:

The following is a summary of the significant functions of this individual's job. He/she may perform other duties, both major and minor, which are not mentioned below, and specific services may change from time to time.
  • Develop and maintain a study level timeline and budget with internal leadership and CRO:
    • Including key milestone deliverables with CRO, vendors as well as site enrollment
    • Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
    • Communicate to leadership internally on progress and issues
    • Management of the study level budget and tracking against budget with all parties
  • Develop study oversight plans for Talaris and in partnership with a CRO; plans will describe our oversight of the study execution with vendors, CRO and sites
    • Review, provide input and guide completion of CRO study related plans (i.e. project management plan, communication plan, monitoring plan, reg submission plans, training plans, risk mitigation plans, study close out plans, etc.)
    • In partnership with other functional areas, participate and provide feedback to other plans (data management, medical monitoring/safety management plan, etc.); participate in UAT as needed
    • In partnership with medical monitor, create an internal data and protocol deviations review plan; ensure feedback and follow up to CRO with any concerns
    • Ability to create a close out plan and ensure CRO, vendors and sites are aligned with deliverables and expectation
  • Create, manage RFP and bid defense process for next wave studies; guide internal reviews and evaluations
  • Participate and review quality plans and audits for the study and provide oversight of CAPA resolution with the CRO, vendors and sites as needed
  • Co-manage vendors with CRO and ensure data quality
  • Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
  • Oversight of the eTMF for the trial and will ensure an audit/inspection ready status
  • Participate and review SOPs for clinical operations and other functional areas as needed


Minimum Requirements:
  • Minimum of a Bachelor's degree in the Life Sciences or equivalent is required
  • Minimum of 4+ years of experience in clinical operations is required
  • Minimum of 2 years of monitoring experience and/or lead Clinical Research Associate experience is required (CRA on-site experience preferred)
  • Experience managing a CRO as well as a complex study in a previous Clinical Trial Manager or Clinical Project/Program Manager position is required
  • Ability to build strong relationships with the sites and CRO including providing feedback as well as oversight
  • Passion for working in a small company environment - including being self-motivated and proactive
  • Ability to think of big picture as well as being adept at detail-orientation
  • Up to 30% travel may be required

Benefits:
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is fully committed to equality of opportunity in all aspects of employment. It is the policy of Talaris to provide equal employment opportunity to all employees and applicants without regard to race, color, religion, national or ethnic origin, military status, veteran status, age, gender, gender identity or expression, sexual orientation, genetic information, physical or mental disability or any other protected status.