Job Details

ID #45865038
State New York
City New york city
Job type Contract
Salary USD competitive competitive
Source Real Staffing
Showed 2022-09-21
Date 2022-09-21
Deadline 2022-11-19
Category Et cetera
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Fully Remote Contract - Clinical Data Manager

New York, New york city, 10045 New york city USA

Vacancy expired!

Title: Contract - Manager, Clinical Data Management

Location: Fully Remote

Duration: 6+ Month contract

About the Company: A global pharmaceutical company

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

About the Role: Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.

Your Main Responsibilities:
  • This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors.
  • This position has strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures.
  • Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements.
  • This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas.
  • Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.
  • Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies
  • Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
  • Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
  • Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable company and regulatory requirements.
  • Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
  • Leads and drives the data review process in collaboration with the study team to ensure data quality
  • Participates in audits and inspections.
  • Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
  • May participate in process improvement initiatives.

Requirements
  • BS/RN in life sciences or related field (or equivalent 3-6 years of experience)
  • 3-6 years of data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit

Vacancy expired!

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