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Title: Clinical Data Manager

Location: Remote

Type: Contract

6 months renewable

We cannot work C2C with any other agency for this role. *

We are seeking a skilled Clinical Data Manager with 7+ years prior CRO management experience, gained at a sponsor company. Must have experience leading Data Management tasks, overseeing the work that is outsourced to the CRO. Experience with Phase III clinical trials is needed as well for this role.

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 in accordance 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 for transfer and/or analyses in accordance with client SOPs.

• Creates and maintains project documentation, including, but not limited to, Data Management Manual, 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 clinical databases, subsequent changes in clinical databases and data validation activities.

• Contributes to upkeep client DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.

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

JOB REQUIREMENTS:

Education: Bachelor’s degree in Mathematics, Science or a related field.

Experience: Minimum 7 Years, required. Phase 3 clinical studies experience highly preferred.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.