- Job Type: Full-Time
- Function: Clinical Research
- Industry: Therapeutics
- Post Date: 09/25/2022
- Email: email@example.com
- Website: talaristx.com
- Company Address: 570 S. Preston St, Suite 400, Louisville, KY, 40202
About Talaris TherapeuticsTalaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders.
The Clinical Trial Manager 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.
Duties and Responsibilities:
- 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
- Performs other duties as assigned.
Minimum Education, Training, and Experience Required:
- 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)
- Prior inspection and/or audit experience
- 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
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Medical / Dental / Vision Insurance
- Company Paid Long & Short Term Disability
- 25 Days Paid Time Off + 11 Paid Company Holiday’s
- 401k with Employer Contribution
- Paid Parental Leave
- Employee Stock Purchase Plan (ESPP)
- Generous Professional Development Policy for Job-Related External Learning Opportunities
- Employee Assistance Program (EAP)
Talaris Therapeutics requires that all employees be fully vaccinated for COVID-19. Proof of vaccination or sincerely held religious belief and/or medical exemption is required upon hire. Talaris Therapeutics will engage in an interactive dialogue process with employees who have documented medical conditions and/or sincerely held religious beliefs that would prevent them from getting vaccinated, in accordance with all applicable laws.
About Us: Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, 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. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.
Equal Employment Opportunity: Talaris Therapeutics is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by emailing us at firstname.lastname@example.org. When emailing, please include a description of your requested accommodation, your name and contact information.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us.