Senior Clinical Data Manager, Clinical Operations

Location
Bedford, MA
Posted
Mar 05, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Senior Clinical Data Manager, Clinical Operations

Location: Bedford, MA

Homology Medicines is seeking a Senior Clinical Data Manager to join our Clinical Operations team. This is a newly created role and will report directly to Head of Clinical Operations. The selected applicant will be responsible for independently leading Data Management aspects of a clinical study. The Senior Clinical Data Manager has thorough knowledge of FDA regulations and industry standards, strong technical skills, and can work collaboratively with vendors to assure that Data Management functions are performed in compliance with regulations and according to study protocol.

Essential Functions and Duties:

  • Develops/executes/reviews project documentation, including, but not limited to, Data Management Manual, eCRF Completion Guidelines, edit checks, query logic and work instructions for assigned projects. Designs and modifies eCRFs.
  • Manages activities including: IxRS, medical coding, developing data validation checks and managing database snapshot.
  • 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 cross-functional team.
  • Participate in the review of Clinical research documents (e.g., Protocols).
  • Participate in UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Participate in UAT of IxRS.
  • Participate in the preparation and presentation of data, when applicable.
  • Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards.
  • Assist in the review of 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.
  • Support the identification, review, evaluation and implementation of new technologies related to clinical data standards.
  • Ensure data management related SOPs are up-to-date and are FDA-compliant
  • Manage the Clinical data management study budgets.
  • Performs other functions as required or assigned (e.g., QC of CSRs, submission-related documents, etc).

 

 

Skills and Experience:

  • Bachelor’s degree in life science/biomedical/medical science with a working knowledge of the clinical/scientific terminology and methods common to the biopharmaceutical setting.
  • Minimum of at least 7 years of relevant experience working in a clinical research environment within biotech/pharmaceutical/CRO preferred, with understanding of the clinical development and data management processes.
  • Vendor management and selection experience.
  • Proficient in clinical data collection and data management tools.
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications such as EDC, CTMS and IxRS.
  • Knowledge of MedDRA coding, CDISC standard, or SAS would be a plus but not mandatory.
  • Intermediate knowledge of research and development activities with experience performing CRF Design activities in a clinical research environment.
  • Knowledge in industry data standards and regulatory data submission requirements, with a focus on SDTM and electronic submission (eSub).
  • Good verbal and written skills, good organizational, interpersonal, and team skills.
  • Create solutions and present to stakeholders.

Interested candidates should forward a cover letter and Resume / CV to careers@homologymedicines.com

 

www.homologymedicines.com