Join Our Crew

Associate Director, Clinical Data Management

Philadelphia, PA

About the Position

The Associate Director, Clinical Data Management will manage all data management (DM) activities from start-up through database closure and archival, overseeing high quality databases for analysis and potential regulatory submissions.

Responsibilities Include

  • Lead data reconciliation of electronic data transfers from vendor to Sponsor.
  • Assist communication with database (DB) vendors on consistent basis to address Clinical teams requests and/or eCRF development activities.
  • Provide Clinical Data Management support to the Clinical team and other cross functional departments as needed.
  • Develop CRF, electronic and/or paper. Design traditional paper CRFs in print layout format to provide ongoing support of eCRFs used in Clinical Research studies.
  • Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms).
  • Develop clinical trial data specifications, including CRF completion guidelines, user requirements, edit rules/checks, query logic and data validations.
  • Participate in UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • TLF Development for DSMB/IDMC and endpoint adjudication committees
  • Participate in the preparation and presentation of data, when applicable.
  • Ensure data compliance by following the established guidelines of national and international regulatory authorities.
  • Assist in the review of routine/interim/final data listings prior to transmission to other groups or inclusion in regulatory submissions.
  • Assist in the gathering of design requirements from stakeholders and organize in a standard format to address the needs of users (e.g., investigator, study coordinator, study monitor) and simplifies data collection and analysis.
  • Provide input and support on data and submission standards to project teams to ensure high quality and timely eSub deliverables that meet industry standards and regulatory requirements; particularly with regard to SDTMIG assumptions and mapping strategies, statistical programming conventions, and CTD-CRT preparation (Define.xml development, CRF annotation, FDA submission expectations, use of Pinnacle 21, and SDTM compliance rule violation resolution).
  • Support the identification, review, evaluation, and implementation of new technologies related to clinical data standards.
  • Participate in data standards process improvement working groups.

Required Qualifications

  • Bachelor’s degree in a science related field.
  • 8 or more years data management and drug development process with expertise in the data management function.
  • Experience managing vendor relationships with at least 4 years’ experience in this area.
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • BLA/NDA/CTD Experience preferred.
  • Experience of data management best practices, standards, library development and maintenance.
  • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Experience of broad drug development process with expertise in the interfaces with the data management function.
  • Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Working knowledge of Clinical database applications such as EDC and CTMS.
  • Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
  • Ensure adherence to functional budget, and provide updates to manager regarding additional, potential spend or cost savings.
  • Experience of CDISC standards, SDTM and TA-specific standards preferred. Experience developing internal data standards and mapping of Medical Concepts is ideal.
  • Intermediate knowledge of research and development activities with experience performing CRF Design activities in a clinical research environment.
  • Good verbal and written skills, good organizational, interpersonal, and team skills.
  • Create solutions and present to stakeholders.

How to Apply

Please email directly to submit an application.

Please include your CV along with the title of the position you are applying for.


Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.