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Clinical Data Manager

Eingestellt von Yoh

Gesuchte Skills: Design, Client

Projektbeschreibung

Yoh has a contract opportunity for a CLINICAL DATA MANAGER to join our client in Whippany, NJ.

JOB OVERVIEW:

Ensure quality and timely clinical data delivery for multiple US local Phase IV clinical projects outsourced to Contract Research Organizations (CROs). Establish appropriate application of data standards, monitor CRO progress, and perform quality assurance review of key clinical data management (CDM) deliverables. He/she may also execute tasks for projects using internal resources.

JOB RESPONSIBILITIES:

- Monitor clinical data quality and progress of trials outsourced; drive corrective actions as needed
- Ensure complete and consistent medical term coding using appropriate standard dictionaries
- Ensure consistency of serious adverse event data across clinical and drug safety databases
- Proactively identify project threats and resolve issues with clinical trial teams; escalate to BMA management if necessary and appropriate
- Ensure clinical databases are structured in alignment with case report forms and data standards; provide technical feedback to CROs as needed
- Act as representative on Clinical Trial Teams, providing leadership on project-level strategy, data validation plans, and data issue identification and feedback.
- Develop presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings as appropriate
- Assist in training and mentoring of new hires upon request
- Help respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues

JOB QUALIFICATIONS:

- Six (6) or more years Clinical Data Management and/or clinical trial operations experience or a Bachelor's Degree and four (4) or more years of clinical data management and/or clinical trial operations experience
- Two (2) or more years of experience in managing outsourced work or working for a clinical research organization
- Demonstrated project management experience in a team environment

SKILLS AND KNOWLEDGE:

- Understanding of clinical data management principles and concepts, database design and development concepts, SAS concepts, medical term coding concepts, clinical trial methodology and GCP, basic medical concepts, and basic statistical concepts
- Ability to use e-mail, standard MS Office applications, and SAS Viewer
- Ability to review high volumes of data for quality issues; attention to detail
- Organizational, planning and project management skills
- Interpersonal, communication, and negotiation skills
- Ability to operate effectively in a team environment

BEHAVIORS:

- Leads and monitors external vendor operations and deliverables
- Works with minimal supervision
- Handles multiple projects
- Can work under pressure to meet deadlines
- Works effectively with internal and external business partners; team player
- Can express disagreement without confrontation/provocation
- Compliant with standards
- Positive attitude; supportive of management

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Zach Stewart

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources .

Yoh, a Day J2W: INFOTECH

Tax Term: CON_W2

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Ref:

SFSF: LS

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    design, client

Yoh