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Job Title: Analyst, Evidence Generation Data Management

12-month contract - W2

Description:

Job Schedule: Candidate allowed to work 100% remote for duration of contract.

SUMMARY

+ The position holder will support end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high-quality deliverables are on time and within budget.

+ The position holder will support the study lead and partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.

+ The position will understand Electronic Data Capture/related applications and industry standards, and fundamental technical skills in working with data received from CROs and other third-party vendors.

Study Responsibilities:

+ Responsible, with strict supervision, for study activities assigned related to the Data Management study setup, conduct, and closeout.

+ Ensure timely, to budget, and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, Database specifications, Database build, interim data cuts, Database lock, and study archiving

+ Must comply with international regulations, with guidance under Manager

+ Ensure inspection readiness, as well as prepare potential audits linked to assigned studies

Vendor Oversight:

+ With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.

Operational Excellence:

+ Participate, with supervision, in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions

+ Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy

+ Any other supporting duties deemed pertinent to the needs of the business (included but not limited to: town halls meetings coordination)

Skills:

+ Must have a minimum of at least 1 or more years of professional pharmaceutical industry experience, or other related healthcare experience (i.e., CRO) with experience related to study activities assigned related to data management, study set up, conduct, and close out.

+ Must have proven expertise and experience supporting post-marketed drug development in either the pharmaceutical industry or within CRO.

Education: Bachelor's Degree Related Sciences required

System One, and its subsidiaries including Joulé, ALTA IT Services, 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.

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Ref: #568-Clinical

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.