Senior Clinical Data Manager

Company: Celldex Therapeutics
Location: New Haven
Posted on: June 21, 2022

Job Description:

OverviewThe Sr. CDM is responsible for managing the data management activities for multiple clinical trials. Will work closely with internal team members and CROs/vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget. New Haven CT location preferred; Remote will be considered with the expectation of travel to CT office at least once/month.Responsibilities

• Oversee CRO data management counterparts for assigned clinical trials and ensure that the outsourced data management objectives are met in accordance with current SOPs, WPDs and timelines and budget.
• Initiate CRF development for new clinical trials and protocol amendments; collaborate with internal team and responsible vendor on CRF development, database design and edit specifications. Ensure established clinical data standards are followed.
• Review CRO Data Management Plans, Data Review Plans and other applicable data management documents for completeness and accuracy.
• Create internal Data Review Plans for review/approval by study team members and coordinate the internal data review process; oversee and track clean patient status.
• Create Data Transfer Plans for external data vendors for review/approval by study team members; perform external data reconciliations as applicable
• Review protocols, Statistical Analysis Plans and statistical outputs taking CRF/Database into consideration.
• Assist in the creation/review of clinical data standards, DM WPDs and Instruction Documents.Qualifications
  • Bachelor's degree in science or similar area with experience
  • 5+ years prior experience in clinical data management
  • Preferred experience with oncology, dermatology, allergy
  • Knowledge of and experience with EDC, ePRO, IWRS and other electronic systems used for clinical data capture. Experience with Medidata Rave is preferred.
  • Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
  • Excellent oral and written communications
  • Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
  • Excellent organizational, multitasking, and priority management skills
  • Ability to work within established timelines, in a fast-paced environment, managing multiple clinical trials, non-study projects, and ad-hoc assignments
  • Experience with clinical data standards
  • In-depth knowledge of data management, including interpretation and implementation of FDA regulations/lCH guidelines, and GCP is required

Keywords: Celldex Therapeutics, New Haven , Senior Clinical Data Manager, Executive , New Haven, Connecticut