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Clinical Trial Manager

Company: Rubius Therapeutics, Inc.
Location: Cambridge
Posted on: June 12, 2021

Job Description:

Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics. Our proprietary RED PLATFORM was designed to genetically engineer and culture Red Cell Therapeutics that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. We are currently enrolling patients in a Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia, and our IND has been cleared by the U.S. FDA for RTX-321 for the treatment of human papillomavirus 16-positive cancers.

We are proud of our passionate, high-performance culture - one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are headquartered in Cambridge, MA, and our manufacturing facility in Smithfield, RI was named 2020 Top 5 Best Places to Work in Rhode Island among medium-sized companies by Providence Business News. We are currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com, or follow us on Twitter and LinkedIn or like us on Facebook.

Summary

We are seeking an experienced Clinical Trial Manager (CTM), to join our growing Clinical Development Organization. This role will be key to leading the planning, execution and oversight of clinical trials in our Oncology program. The position will entail managing all aspects of trial operations (from study launch to study close) while ensuring quality in accordance with ICH GCP and regulatory compliance. This role is responsible for internal cross-functional study team activities, as well as external communication and oversight of vendors (e.g., CROs, Central labs, etc.). As the key leader overseeing trial activities, the CTM builds strong relationships to facilitate integrated team functionality across all vendors, sites, and study team members.

Responsibilities

  • Ensures appropriate oversight of Contract Research Organizations (CROs), clinical trial sites and other external vendors, including assessment of performance against contractual obligations.
  • Leads development, distribution and execution of operational activities outlined in various study plans, SOPs, study procedures, etc. including management of critical study documents (i.e. ICFs, study plans, site materials, etc.)
  • Builds solid relationships with key counterparts at CRO(s) and other external vendors
  • Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
  • Through oversight of the CRO, drives start-up, enrollment, clinical monitoring activities, clinical site compliance and tracks metrics from CROs, central labs, and other external vendors
  • Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports, conducting co-monitoring visits at clinical sites as needed, reviewing data listings or profiles at specified timepoints)
  • In partnership with QA, supports and participates during vendor selection, qualification, and audit activities
  • Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues appropriately in a timely manner
  • Drives quality efforts to proactively identify and manage risks to trial quality and ensure inspection readiness
  • Partners with Clinical Supply and Technical Operations to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction

Qualifications & Education

  • Bachelor's degree (scientific or healthcare discipline preferred) plus at least 5+ years in clinical operations or drug development
  • Experience in oncology strongly preferred
  • Experience with cell therapy will be favorably considered
  • Sponsor-level management of CROs with multiple vendors and complex protocols required
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment
  • Strong working knowledge of ICH GCP and application to the conduct of clinical trials
  • Demonstrated self-starter and team player with strong interpersonal skills.
  • Ability to organize and manage multiple priorities
  • Excellent problem-solving skills
  • Ability to work in a fast pace, cross-functional, start-up environment
  • Ability and willingness to travel 10-15% of the time

EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.

Keywords: Rubius Therapeutics, Inc., Cambridge , Clinical Trial Manager, Other , Cambridge, Massachusetts

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