Sr. Clinical Data Manager

1 week ago

Princeton, United States pmvpharma Full time
Job DescriptionJob DescriptionSr. Clinical Data Manager, Clinical Development - hybrid/remote

PMV Pharma is developing first-in-class p53 regulators for the treatment of cancer. Bringing together leaders in the field to utilize over three decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus.

PMV Pharmaceuticals is currently looking for an individual to join the company as a Sr. Clinical Data Manager. The primary responsibility for this position is the management of all clinical data activities at PMV. This role will report to the Sr. Director, Biostatistics and Data Analytics.

Job Description

The Sr. Clinical Data Manager (CDM) will be responsible for leading data management activities across clinical development programs. This role will serve as a point of contact for PMV sponsored studies for CRO CDM counterparts and internal team members.  This role will oversee internal data management activities including but not limited to, PMV's EDC URL, data reviews, and reporting into cross-functional team meetings. The Sr. CDM will be responsible for overseeing outsourced data management activities across vendors (e.g. DMP development, data access plans, eCRF builds, data cleaning, data readiness planning and progress for key deliverables, external data transfers, etc.). The Sr. CDM is responsible for ensuring that deliverables are executed on time, of high quality and in accordance with protocol requirements, ICH GCP guidelines, regulatory requirements, third party vendor specifications, and PMV procedures.

Responsibilities
 
  • Participate in clinical data strategy planning for program and study key deliverables. Facilitating cross functional conversations in terms of data strategy.
  • Contribute to development of detailed CDM related study timelines with the CRO for data deliverables.
  • Work closely with study clinical trial managers to support maintenance of overall study (project) timelines and milestones.
  • Manage/ oversee data management activities to ensure data integrity and data readiness is maintained across PMV clinical studies.
    • EDC design, build, UAT (CRFs and Edit Checks)
    • Data collection, reconciliation, processing, coding, reporting, validation
    • Review and approve data management documentation and specifications (data management plans, external data transfer agreements, validation plans etc.)
    • Review and approve other clinical development documents as needed (protocols, SAP, training materials, charters, blinding plans, etc.)
    • Coordinate database snapshot and lock activities
  • Coordinate and communicate with vendors and PMV vendor and sample managers, as applicable, on a consistent basis to address team requests, project plans and/or eCRF development.
  • Accountable for ePRO/eCOA data collection methods (portable devices, etc..); ensure design of data collection meets requirements and protocol objectives.
  • Assist in defining and/or creating data listings, summary table validation, data specifications, participate in preparation and presentation of data.
  • Process data transfers in preparation for statistical review and/or data management audits
  • Support inspection readiness, quality compliance and training initiatives pertaining to data management activities.
  • Ensure data system compliance by following the established guidelines of national and international health authorities.
  • Author and contribute to development/update of clinical development SOPs and work instructions.
  • Manage / mentor junior data management staff as applicable.

Qualifications and Experience
 
  • Bachelor’s degree or higher in scientific or healthcare discipline preferred, with at least 8 years of progressive experience in data management within the biotech, pharmaceutical industry.
  • Experience working in an outsourced data management model is required.
  • Prior experience with Medidata Rave is required, URL administration experience a plus.
  • Proficient in clinical data collection, cleaning, and analysis for Phase I-IV clinical and healthy volunteer trials
  • Experience in development and maintenance of program and/or clinical trial timelines is required, MS Project experience preferred.
  • Experience in oncology is required, early phase drug development, and rare diseases is preferred.
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries and quality control processes.  Prior experience with reporting software (e.g. Crystal Reports, Business Objects, Spotfire, etc.) a plus
  • Strong understanding of GCP, ICH and FDA requirements as applicable for clinical data management (i.e. data integrity standards and guidelines)
  • Prior experience supporting a BLA or NDA filing preferred.
  • Ability to manage multiple initiatives and shifting priorities with a small company environment.
  • Prior experience in management and/or mentoring of data management staff.
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Benefits
PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Plan and much  more.

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