Apply on Employer Site

Beacon Hill · 19 hours ago

Remote - Senior Clinical Data Manager

United States

Contract

Remote

Senior Level, Lead/Staff

$90/hr - $100/hr

8+ years exp

Beacon Hill is a highly reputable biotechnology corporation currently hiring a qualified Senior Clinical Data Manager to work remotely in the United States. The role involves leading all aspects of the data management process for late phase clinical programs, ensuring high-quality data collection, and developing clinical data management standards and processes.

Staffing Agency

H1B Sponsor Likely

Hiring Manager

Andrew Osborn

Responsibilities

Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirements

Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements

Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates

Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial

Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables

Develop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)

Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines

Maintain study DM related documents for inspection readiness

Develop data transfer agreements with external vendors

Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)

Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions

Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy

Serve as a subject matter expert on data management systems and processes

Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates

Qualification

Clinical data managementLate phase oncology trialsEDC configurationVeeva CDMS systemCDISC standardsMedDRAWhoDrug codingVerbal communicationWritten communicationCritical thinkingAttention to detailTeam player

Required

Bachelors in life sciences or related discipline

8 or more years of experience in clinical data management

Requires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements

Strong verbal and written communication and critical thinking skills

Excellent ability to manage competing priorities in a changing environment

Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines

Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization

Self-motivated and takes pride in your work

Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships

Attention to detail, ability to proactively identify issues and address with solutions-oriented approach

Preferred

Strong experience with late phase oncology trials is preferred

Experience in Veeva CDMS system is a plus

Experience with MedDRA and WhoDrug medical coding

Company

Beacon Hill

Glassdoor3.9

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.

Founded in 2000

Boston, Massachusetts, USA

1001-5000 employees

http://www.beaconhillstaffing.com

H1B Sponsorship

Beacon Hill 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 (38)

2024 (94)

2023 (76)

2022 (60)

2021 (77)

2020 (86)