RWE Data Manager

Binding Minds Inc. (Certified Disability Owned Business Enterprise); United States; Remote; USD 120,000 - 180,000; Full time

Job summary

A leading company is seeking a Manager for Evidence Generation Data Management to oversee data management services for studies, ensuring high-quality deliverables and compliance with industry standards. This remote position requires a Bachelor's degree in Sciences and at least 4 years of experience in the pharmaceutical industry, preferably in oncology. The role involves collaboration with CROs and stakeholders to optimize data management processes and maintain data integrity.

Qualifications

• 4+ years of professional pharmaceutical industry experience.
• Expertise in oncology therapeutic area preferred.
• Knowledge of Electronic Data Capture and related applications.

Responsibilities

• Manage end-to-end delivery of data management services for assigned studies.
• Ensure compliance with regulatory guidelines and data quality.
• Participate in Global Evidence Generation initiatives.

Skills

Data Management

Collaboration

Project Management

Data Integrity

Education

Bachelor's Degree in Sciences

Job description

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Binding Minds Inc. (Certified Disability Owned Business Enterprise) provided pay range

This range is provided by Binding Minds Inc. (Certified Disability Owned Business Enterprise). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $70.00/hr

Direct message the job poster from Binding Minds Inc. (Certified Disability Owned Business Enterprise)

Lead HR Recruiter | Talent Acquisition Specialist | Recruitment & Staffing | Helping hand

Title - Manager Evidence Generation Data Management

Duration - 1 year

Location - Basking Ridge, NJ

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

SUMMARY

· The position holder will manage, with direction, 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 partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.

· The position will have 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.

· The position holder may act as a Biometrics Project Manager to plan and coordinate cross-functional Evidence Generation execution of the study deliverables

RESPONSIBILITIES

Study Responsibility:

· Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and closeout. Ensure timely 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

· Leads the data review process in collaboration with the study team to ensure data quality

· Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities. Must comply with international regulations

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

· 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.

· Participates in drafting requests for proposals for CRO selection. Reviews baseline budget and timelines. Contributes to budget management and activities across the project duration

Operational Excellence

· Participate 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 duties deemed pertinent to the needs of the business

· Must have 4 + years of professional pharmaceutical industry expertise or related healthcare experience (i.e., CRO) supporting end-to-end delivery of data management related to post-marketed drug development.

· Expertise within the oncology Therapeutic Area is highly preferred.

· Expertise in late-phase projects would be highly preferred

Education: Bachelor's Degree in Sciences required

Seniority level

• Not Applicable

Employment type

• Contract

Job function

• Analyst, Strategy/Planning, and Science
• Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Hospitals and Health Care

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