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
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