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Clinical Data Associate II Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

CLINICAL DATA ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in CAMBRIDGE, MA.

WHAT YOU'LL BE DOING:

- The Sr. Clinical Data Associate will provide leadership and comprehensive data management expertise in the development and maintenance of data collection tools and processing of clinical data for longitudinal observational rare disease registries in support of scientific, clinical, regulatory and commercial goals.
- Oversee Functional Service Provider (FSP) in data validation engagement to ensure clinical data are processed according to the Data Review Guidelines (DRGs) and Standard Operating Procedures (SOPs).
- Develop data management QC plans and quality control checks for the processing of clinical data.
- Work with the Medical Director and project team in designing and developing Case Report Forms (CRFs).
- Develop and maintain the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
- Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing.
- Create transformation rules and mappings for the transition of clinical trial data between databases (if needed).
- Collaborate with a highly motivated and experienced data management team on process improvement and implementation of new technology.
- Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines for patient workflow (enrollment, transfer) and processing clinical data.
- Collaborate with data management peers and other functional departments to define and develop operational type reports to assist with data exploration and metrics.
- Develop training materials and provide training to Site Operations personnel.
- Participate and take leadership role for data management in project team meetings.
- Entails effective communication skills (oral and written) and interpersonal skills.
- Create and manage data management workflow documentation, to include, but not limited to; Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan.
- Work with Electronic Data Capture (EDC) vendors and project field team to troubleshoot database bugs/issues to resolution. Requires analytical and problem-solving skills, with good attention to detail.
- Responsible for tracking individual project tasks and overall project timelines.
- Review and approve vendor contracts, change orders and invoices.

YOU NEED TO BRING TO THE TABLE:

- Education: Bachelor's degree in related science/technical discipline required or a minimum of five (5) years data management experience in Pharmaceutical/Biotechnology industry
- Two to four (2-4) years of experience in developing database and validation specifications
- Two to four (2-4) years of experience with Electronic Data Capture (EDC)
- One to two (1-2) years of experience with Reporting Tools (eg, BOXI, SAS, Business Objects)
- One to two (1-2) years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Cambridge, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh