clinical data manager Durham, NC

MM INFOTECH

Full Time Durham, NC 119597 - 75724 USD ANNUAL Today

Job description

Responsibilities Serves as primary Data Manager contact for assigned studies, including representation on project teams and working with
CRO’s performing data management tasks for assigned study.

Coordinates, leads and performs clinical data management activities for assigned studies in accordance with

Client's SOP’s and policies and practices including, not limited to:

Monitors data clean-up process performed by CRO’s from study start-up through data archiving.
Provides data for analysis
Coordinates activities including: medical coding; data validation checks and database snapshot
Prepares and distributes project status reports to project team and management.
Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or

analyses in accordance with Client SOP’s.

Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF

Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and
modifies CRF.

Responsible for the initiation and approval of the building, testing and validation of clinical databases,

subsequent changes in clinical databases and data validation activities.

Contributes to upkeep Client DM outsourcing strategies and long-term relationships with outsourcing

partners with objective of ensuring data quality and efficiencies through data and process standardization.

Works with study team and coordinates all data management functions. Manages coordination of CRO data

manager and project team to ensure that tasks are performed according to policies and procedures.
Adheres to procedures surrounding retention of data, records, and information for clinical studies

Qualifications:

Bachelor degree in Pharmaceutical Science or a related field, along with 3 or more years of clinical data
management experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or
ophthalmology experience a plus.
Self directed and comfortable working in teams with the ability to work and operate independently within a tight
deadline environment. High degree of creativity, latitude and attention to detail required.

Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project

mgmt skills. Strong written and oral communication skills required.
Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS
required. Experience with JMP and SAS a plus.