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Clinical Data Manager I
1 week ago
Overview:
The Clinical Data Manager is responsible for delivery of an entire clinical trial. Is sponsor facing and works with study project managements and technical data management team to meet the design specs, monitor the health of the trial, ensure quality and data reconciliation.
Essential Functions:
- Ensures clinical trial databases meet project requirements by:
- Attending and participating in sponsor meetings
- Managing all data management deliverables for assigned studies
- Ensures the plan for data management is properly executed by:
- Understanding the requirements for study implementation and data collection
- Collaborating with project team to develop study-specific edit check criteria
- Defining, running, and reviewing edit checks and resolving discrepant data
- Maintaining organized, complete, and up-to-date study documentation
- Performing study setup, specifications, and obtaining approvals as needed
- Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
- Keeping supervisor informed of project status
- Ensures the accuracy and consistency of clinical databases by:
- Reviewing data and identifying errors/inconsistencies
- Collaborating with appropriate project team to resolve data issues
- Tracking outstanding issues and following-up until resolution
- Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
- Other duties as assigned
- Bachelor's degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
- 1 - 2 years' experience in comparable position within
- Working knowledge of relational database organization and validation
- Proven ability in problem solving
- the pharmaceutical, biotech or CRO industry experience preferred
- Understanding of clinical trial terminology desirable
- Familiarity with SAS desirable
- Experience working with office productivity tools including Word, Excel and Access preferred
Headquartered in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro's multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro's quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by the company's industry-leading software informatics platforms, VivoQuant and iPACS, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.
Invicro is an Equal Opportunity Employer. We maintain a drug-free work environment. All qualified applicants will receive consideration for employment without regard to actual or perceived race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, citizenship status, sex or gender (including pregnancy, childbirth and related medical conditions), parental status, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, political affiliation or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Invicro does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Invicro. Such resumes will be deemed the sole property of Invicro and will be processed accordingly.
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