Manager Evidence Generation Data Management

HireTalent; Basking Ridge (NJ); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company is seeking a Manager Evidence Generation Data Manager to oversee data management services for pharmaceutical studies. This role requires collaboration with internal and external stakeholders to ensure high-quality deliverables and compliance with industry standards. Candidates should have a minimum of 4 years in the pharmaceutical industry, with a preference for oncology expertise and experience in late-phase projects.

Qualifications

• 4+ years in the pharmaceutical industry or related healthcare experience.
• Expertise in oncology therapeutic area preferred.
• Experience in late-phase projects highly preferred.

Responsibilities

• Manage end-to-end delivery of data management services for assigned studies.
• Ensure timely and accurate completion of Data Management deliverables.
• Oversee vendor delivery to ensure compliance with protocols and regulations.

Skills

Data Management

Collaboration

Data Quality

Regulatory Compliance

Operational Excellence

Job description

Job Title: Manager Evidence Generation Data Manager

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

SUMMARY

1. 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.
2. The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
3. 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.
4. 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:

1. Responsible, with supervision, for study activities related to Data Management study setup, conduct, and close-out. Ensure timely, within budget, and accurate completion of Data Management deliverables, including but not limited to the Data Management Plan.
2. Database specifications, database build, interim data cuts, database lock, and study archiving.
3. Lead the data review process in collaboration with the study team to ensure data quality.
4. Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities, ensuring compliance with international regulations.
5. Ensure inspection readiness and prepare for potential audits linked to assigned studies.

Vendor Oversight:

1. With supervision, responsible for routine oversight of vendor delivery to ensure compliance with the protocol, applicable regulatory guidelines, policies, SOPs, and other relevant standards.
2. Participate in drafting requests for proposals for CRO selection, review baseline budgets and timelines, and contribute to budget management throughout the project.

Operational Excellence:

1. Participate in Global Evidence Generation initiatives to improve process harmonization and efficiency, and develop innovative solutions.
2. Maintain current knowledge of industry best practices in Data Management methodology, Data Integrity, and Data Privacy.
3. Perform any other duties relevant to the needs of the business.

Minimum Requirements

• Must have 4+ years of professional pharmaceutical industry experience or related healthcare experience (e.g., CRO) supporting end-to-end data management in post-marketed drug development.
• Expertise within oncology Therapeutic Area is highly preferred.
• Experience in late-phase projects is highly preferred.