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Clinical Data Manager



Data Science
Boston, MA, USA
Posted on Thursday, April 20, 2023

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Over the past five years, PathAI has developed partnerships with many of the top global biopharmaceutical companies and biotechs, with the goal of integrating digital & computational pathology into the drug development process from early R&D through to commercial. As drug development increasingly trends towards personalized and targeted indications, computational pathology offers opportunities to enable faster and cheaper drug development, bringing lifesaving treatments to patients. To meet the constantly growing demand from our life sciences partners, PathAI is building out the Biopharma Partnerships team.

Where You Fit

PathAI is looking for an experienced Clinical Data Manager to support our expanding portfolio of clinical trial studies. We are looking for candidates who have developed and executed the full scope of GCP data management processes to support translational research as well as IDE studies.

What You’ll Do

  • Support ongoing allocated studies with data operations.
  • Oversees operational scope and plans to achieve data delivery milestones on-time.
  • Proactively identifies barriers to timely and successful data transfers and proposes solutions to same.
  • Develops Data Transfer Agreements (data deliverables, format and timelines) for studies and serves as the main point of contact for internal and pharma teams on data deliverables.
  • Works collaboratively with cross-functional teams (such as Clinical Operations, Laboratory, Quality and Regulatory Affairs), to ensure timely, accurate and compliant data transfers.
  • Identify and build CRF/EDC systems to support CDx study regulatory reports.
  • Setup folder structure for all new studies in study repository/Trial Master File (TMF) as relevant.
  • Expertise with data format requirements example CDISC STDM and integration requirements with various EDCs.
  • Monitor archiving of study documentation in study repository and trial master file as relevant as a study is ongoing and at closure.
  • Track sample processing and deliver study specific sample analysis status tracker reports to clinical program leads or clinical trial managers identifying samples that have been accessioned, are on hold/ quarantined, and/or have failed.
  • Monitor query process and query partners/collaborators to obtain missing information.
  • Complete documentation and study specific intake forms in the CRM/Clinical Trial Management System.
  • Manage sample return and destruction process for all Partners/Collaborators.
  • Submit final report for Pathology approval.
  • Upload, enter, and maintain study sample data in PathAI’s data management and reporting systems.
  • Handle query management and resolution.
  • Perform quality control and ensure accuracy of all data provided to pharmaceutical partners.
  • Ensure quality standards for data reporting are met, including compliance with HIPAA, GDP, and GCP.
  • Proactively identify and raise issues related to data integrity and process improvements; provide recommendations for resolutions as needed.
  • Coordinate and communicate all relevant study activities to ensure timely delivery of partner milestones.
  • Collaborate cross-functionally with sub-teams including Data Management, Clinical Operations, Lab Operations and Quality, Regulatory regarding
  • Plan, manage and coordinate all data management activities for assigned program(s) to ensure consistency of clinical data standards across programs.
  • Has the ability to manage multiple complex projects in parallel and is agile while being highly focused on quality requirements.
  • Authors and maintains (in Trial Master File (TMF)) data management documentation from study start-up to database lock such as SOPs, process flow maps, data management plans, case report forms, data transfer specifications and clinical database specifications
  • Manage timelines across multiple internal and external cross-functional teams.
  • Brings a strong understanding of GCP’s, ICH, and knowledge of regulatory requirements in support of successful CDx submissions and an ability to communicate same to build internal programs

What You Bring

  • Bachelor’s degree (or related experience) and six plus years work experience in a related discipline
  • Demonstrated ability to execute as a data manager for clinical studies. Experience working as a data manager on CDx studies is a plus.
  • Strong analytical and problem-solving skills
  • Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
  • Familiarity with pharma clinical trials and drug R&D process is a must.
  • Programming proficiency in Python, SAS.
  • Experience with database locks and data management plans
  • Ability to be a self starter in a fast paced startup environment. Ability to help develop processes and standardization with minimal supervision.
  • Solid organizational and business assessment skills is required
  • Team player willing to work in a fast paced environment with cross functional teams internally and externally
  • Excellent written and verbal communication skills in English
  • Experience with project management and clinical trials software e.g. RAVE, INFORM.
  • Detail oriented with an appetite to drive tasks to completion

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.