Clinical Operations and TMF Manager

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.candeltx.com for additional information.

This role is a highly visible position and of significant impact to the company. You will participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved for a regulatory inspection. You will exhibit strong project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines. You will provide support to TMF implementation, internal audits, and regulatory inspections. We are on a critical mission to bring quality solutions to patients. This role will help us drive forward towards that pinnacle goal of truly putting patients first.

Responsibilities:

In close collaboration with Clinical Program/Project Manager(s):

  • Oversees the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Candel SOPs).
  • Works cross-functionally across study teams.
  • Liaisons between the clinical study teams, quality, and regulatory teams.
  • Oversight of TMF to ensure ongoing completeness and accuracy is maintained.
  • Works with Clinical Operations study teams to implement and promote best practices, standardizations, utilization, and optimization – keeping in mind TMF Inspection Readiness and Risk-based QC efforts.
  • Monitors quality issue resolutions specific to TMF findings.
  • Attends and participates in study specific meetings.
  • Contributes to TMF inspection readiness, SOP development/revision, and tracking certain KPIs (Key Performance Indicators).
  • Performs routine and ad hoc quality and/or completeness checks in the Trial Master File – focusing on identifying trends in completeness, quality, and timeliness.
  • Participates in CRO and study vendor review, selection, and negotiation.
  • During early engagement with select Strategic Partner(s) and/or other CROs, leads the development of the operational strategy review; focuses on ensuring accurate assumptions are applied and robust risk management plans are in place.
  • Provides oversight/support/guidance to Strategic partners/CROs to ensure study issues are addressed and resolved rapidly and supervision of performance for activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
  • Communicates study status, cost, and issues to Clinical Operations Lead; serve as escalation point for third party vendors managed by Strategic Partner and/or CROs
  • In partnership with data management, reviews and pressure tests all database timelines and plans.
  • Ensures studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
  • Ensures good data feeds and/or connectivity from Strategic Partner(s) and/or CRO(s) into Candel CTMS

Requirements:

  • Bachelor’s Degree or equivalent required; Life Sciences preferred.
  • 7+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years in clinical study TMF/document management.
  • Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.
  • Direct experience with managing TMF, experience with multiple eTMF platforms and knowledge of DIA TMF reference model preferred.
  • Experience with TMF migration advantageous.
  • Excellent organization and collaboration and communication skills with a demonstrated ability to work independently with exceptional attention to detail
  • Can participate and work effectively on multiple cross-functional teams, understanding that relationships are key and having strong interpersonal skills
  • Ability to make decisions, deliver on commitments, share knowledge, acknowledge other’s achievements, and collaborate with peers to meet objectives or timelines in a rapidly changing environment.
  • Demonstrated successful experience in project/program management and matrix leadership who can thrive in a smaller company environment and pace
  • Good communication skills with an ability to be a team player willing to roll-up your sleeves and get the job done
  • Excellent teamwork, organizational, interpersonal, and problem-solving skills
  • Fluent business English (oral and written)

Corporate Culture:

A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.  Please visit www.candeltx.com for more information.

We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.  For consideration, please submit CV.

Interested candidates please submit your resume to careers@candeltx.com