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Clinical Data Manager

Joulé

Village of Tarrytown (NY)

Remote

USD 100,000 - 125,000

Full time

18 days ago

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Job summary

A leading company seeks a Clinical Data Manager for a fully remote, 6-month renewable contract. Responsibilities include coordinating data management activities, monitoring CROs, and ensuring compliance with study protocols. Ideal candidates will have extensive oncology/hematology experience and strong sponsor management skills.

Qualifications

  • 5+ years recent sponsor experience.
  • 3+ years recent experience in Oncology/Hematology.
  • Ability to work for any employer in the US.

Responsibilities

  • Coordinates clinical data management activities for assigned studies.
  • Monitors data clean-up processes performed by CROs.
  • Creates and maintains project documentation.

Skills

Oncology experience
Data management
Vendor management
CRO collaboration

Education

Bachelor's degree in Mathematics, Science or related field

Job description

Job Title: Clinical Data Manager

Location: Fully remote - must be US Based



6 month Contract - renewable

Compensation: $65 - $75 hourly



W2 contractors only - we cannot work C2C with any other agency

Job Title: Clinical Data Manager

Location: Fully remote - must be US Based



6 month Contract - renewable

Compensation: $65 - $75 hourly



W2 contractors only - we cannot work C2C with any other agency



Minimum Requirements:

- 5+ years recent sponsor experience

- Vendor CRO management - DM work is outsourced to CROs

- Oncology/Hematology - 3+ years recent experience needed

- Ability to work for any employer in the US - this is a contract assignment

- BS degree or higher completed

SUMMARY:

Works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM). Works with involved parties to assure that DMM is prepared according to company SOPs and in compliance with client’s data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with client’s SOPs and policies and practices.



JOB RESPONSIBILITIES:



• Serves as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.

• Coordinates, leads and performs clinical data management activities for assigned studies inaccordance with client’s SOPs and policies and practices including, not limited to:

o Monitors data clean-up process performed by CROs from study start-up through data archiving.

o Provides data for analysis.

o Coordinates activities including: medical coding; data validation checks and database snapshot.

• Prepares and distributes project status reports to project team and management.

• Functions as DM team leader responsible for ensuring databases are validated and ready fortransfer and/or analyses in accordance with clientSOPs.

• Creates and maintains project documentation, including, but not limited to, Data ManagementManual, CRF Completion Guidelines and validation specifications, and work instructions for assigned

projects. Designs and modifies CRF.

• Responsible for the initiation and approval of the building, testing and validation of clinicaldatabases, subsequent changes in clinical databases and data validation activities.

• Contributes to upkeep of clientDM outsourcing strategies and long-term relationships withoutsourcing partners with objective of ensuring data quality and efficiencies through data andprocess standardization.

• Works with study team and coordinates all data management functions. Manages coordination of CROdata manager and project team to ensure that tasks are performed according to policies and

procedures.



JOB REQUIREMENTS:



Education

• Bachelor’s degree required in Mathematics, Science or a related field, along with 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.



Experience

• 3 – 5 Years

• Previous oncology and/or hematology experience needed


System One and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.



System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.



#M-



#DI-



Ref: #568-Clinical

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Research, Analyst, and Information Technology
  • Industries
    Staffing and Recruiting

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