Clinical Data Manager is responsible for reviewing an******** clinicaldata generate******** the imaging portion of sponsor clinical trialsconducte******** various therapeutic areas.
Primary Responsibilities
Ensures clinical trial databases meet project requirements by:
Performing all data management deliverables for assigne********
Attending an******** in client meetings as requested
Ensures the plan for data management is properly execute********:
Understanding the requirements for study implementation an********collection
Collaborating with project team to develop study-specific edit checkcriteria
Def******** runn******** an******** edit checks an******** discrepantdata
Maintaining organ******** complete, an********-to-date studydocumentation
Performing study setup, including TF ******** database structure,spec******** an******** an******** approvals as needed
Coordinating an******** the receipt an******** of electronic orancillary data receive******** outside sources (e.g., datareceive******** other central laborator******** CRO's, or Sponsors).
Keeping supervisor informe******** project status
Ensures the accuracy an******** of clinical databases by:
Reviewing data an******** error********
Collaborating with appropriate project team to resolve data issues
Tracking outstanding issues an********-up until resolution
Ensuring accuracy in manipulation an******** of clinical data an********CDM activities are carrie******** according to regulatory guidelines
Secondary Responsibilities
Maintains Quality Service an******** Standards by:
Adhering to all Bioclinica Clinical Data Management (CDM) proce********pol******** an******** instructions
Rea******** understanding an******** to applicable Standar********Procedures (SOPs)
Assisting in establishing an******** departmental standards
Participating in the review an******** of company SOPs relate******** DMServices
Contributes to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to a******** to the organization
Helping others to achieve results
Performing other duties as assigned
Maintains Technical an******** Knowledge by:
Attending an******** in applicable company-sponsore********
Qualification********
Education:
Bachelor’s degree in Computer Sc******** Life Sciences or relate********preferred, or equivalent experience required
Experience:
2+ years’ experience in comparable position within thepharmaceut******** biotech or CRO industry required
Working knowledge of relational database organization an********
Familiarity with SAS desirable
Experience working with office productivity tools including Word, Excelan******** preferred
Understanding of clinical trial terminology desirable
Proven ability in problem solving
Additional skill se********
Ability to work independently in a group setting; ability to adjust tochanging priorities
Excellent attention to detail
Strong interpersonal an******** sk******** both verbal an********
Strong documentation an******** skills
Ability to project an******** a professional an******** attitude
Working condition********
Travel: 0-15%
Lifting: 0-25lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluatesqualifie******** without regar******** race, color, rel********gen******** national or******** age, sexual or******** gender identityor express******** protecte******** status, disability/handicap statusor any other legally protecte********
This position description shoul******** be deeme******** inclusive.Additional requirements an******** may be assigned. At all t********employees are expecte******** adhere to company policies an******** SOPs.