Job Opportunities

Clinical Data Manager

As part of the Clinical Development and Medical Affairs team, the Clinical Data Manager (CDM) is responsible for timely and high-quality data management deliverables for ongoing clinical trials and new clinical development initiatives. The position reports to the Director of Clinical Data Management. The successful candidate will provide oversight of outsourced service providers in the management of data from clinical trials, including database development, data processing, and compliance with SOPs and industry standards. Knowledge and experience in clinical data reporting and visualization is a big plus. Other responsibilities are described as follows:

Essential Responsibilities

  • Serve as Clinical Data Manager for one or more clinical trials assuming accountability for all data management activities by providing oversight of tasks performed by CDM service providers
    • EDC design, build, UAT (CRFs and Edit Checks)
    • Data collection, processing, coding, reporting, validation
    • Review and approve external data transfer agreements
    • Coordinate database lock activities including approval to lock
  • Ensure work carried out by CDM providers is in accordance with internal expectations, applicable SOPs and working practices to deliver high quality data management for all studies as assigned.
  • Interact and collaborate with biostatisticians and statistical programming providers as needed to review statistical analysis plans, TLF shells, data deliverable specifications, SDTM and ADaM data deliveries, and other data related deliverables.
  • Serve as a technical resource to the internal study team regarding CDM standards, tools, data provisioning, and reporting
  • Facilitate and support internal periodic clinical data quality review, maintain log of identified data issues, and communicate issues to CDM service provider for resolution
  • Proactively drive quality and efficiency to meet timeline and milestones for data management, ensuring operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
  • Assist with the development, maintenance, and implementation of standard operating procedures (SOPs), and other forms of documentation
  • Ensure the required study-specific data management documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.

Supplemental Responsibilities

  • Generate specialized data sets, listings, reports, and visualizations from clinical trial data
  • Write and review data set specifications
  • Fulfill data requests from internal clinical development team members.
  • Produce descriptive tabular analyses including variable frequencies, cross-tabulations, and summary statistics, and graphical analyses including scatter plots, bar charts, and histograms.

Qualifications

  • Bachelor's degree or higher with 5+ years Data Management experience in the pharmaceutical/biotechnology industry
  • Oncology clinical trial experience preferred
  • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
  • Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
  • CRO and vendor oversight experience
  • Working knowledge of CDISC standards (SDTM, ADaM)
  • Strong project management skills
  • Strong verbal and written communication skills
  • A proven track record of being a detail-oriented, motivated, self-starter, strategic with time management and organizational skills

Supplemental Qualifications

  • 1+ years of programming experience using standard data science tools (such as R, SAS, python) for data management including writing programs to manipulate and process data to join data sets, derive new variables, edit existing variables, and reshape data files to suit specific reporting needs.
  • Experience with data visualization tools (such as SpotFire, Power BI)
  • Strong skills using Microsoft Excel, Pivot Tables, Power Query, and/or VBA


PMV provides 100% employee covered medical benefits, a generous PTO policy, competitive salaries, equity options, Employee Stock Purchase Plan, Employee Referral Plan, and much more.

How to Apply

To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com or apply through our Online Portal.


PLEASE, NO PHONE CALLS or AGENCIES

PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.