Apply on Employer Site

Advanced Clinical · 3 hours ago

Senior Lead Data Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

4+ years exp

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. The Senior Lead Data Manager serves as the primary point of contact for data management and is responsible for oversight of all data management activities for their assigned studies, ensuring accuracy and completeness while managing a team.

BiotechnologyConsultingHealth CareInformation TechnologyPharmaceuticalStaffing Agency

Culture & Values

H1B Sponsor Likely

Responsibilities

Follow departmental and company procedures with quality

Coordinate and ensure the accuracy and completeness of all data management activities; including oversight of assigned study team member activities and external vendors

Serve as the study project manager for biometrics stand-alone services

Conduct and participate in meetings as applicable for the scope of work, representing data management services for assigned studies

Facilitate cross-functional meetings for biometrics stand-alone studies

Present at study kick-off meetings, investigator meetings, client meetings, etc

Author and maintain all study start-up documents; including, but not limited to eCRFs, Data Management Plan, Edit Check Specifications

Review and finalize documents developed by other data management team members such as the eCCGs, Data Transfer Specifications, etc

Facilitate and participate in all study start-up activities; including eCRF development, database programming, user acceptance testing, study start-up documentation, supplemental module setup/integration (i.e, RTSM, ePRO) etc

Maintain the study database for assigned studies; drive all required mid-study update activities

Create and maintain study timelines

Author all database lock documentation for assigned studies

Oversee all data management activities; including discrepancy management, reconciliation, coding, listing/report programming, metric reporting, local lab handling, archival etc

Ensure completion and accuracy of data transfer specifications; coordinate the receipt of data transfers

Ensure awareness of and adherence to the contracted scope of services for assigned studies; identify change orders

Provide input on monthly financial reporting for assigned studies

Participate in business development meetings, presenting data management in proposals

Prepare all database lock documentation

Ensure the completeness of the trial master file

May participate in department initiatives and process improvements

May participate in the development and revision of department SOPs

May serve as subject matter expert

May provide training and mentoring for other Lead Data Managers

Perform other duties as requested by management

Qualification

Data management experienceClinical research knowledgeProject management skillsCommunication skillsOrganizational skillsAttention to detailMentoring skillsTeam leadership

Required

Excellent oral and written communication skills, organizational skills, and attention to detail are required

Minimum of 4 years direct data management experience in pharmaceutical development, CRO, or clinical research environment; with at least 1 year in a direct lead data manager role

Preferred

Bachelor's Degree preferred, equivalent combination of education and relevant experience may be considered

Working knowledge of clinical research best practices preferred

Company

Advanced Clinical

Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services.

Founded in 1994

Deerfield, Illinois, USA

501-1000 employees

http://advancedclinical.com

H1B Sponsorship

Advanced Clinical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (4)

2023 (1)

2022 (3)

2021 (5)

2020 (8)