200+ applicants

Company

Original Job Post

Clinical ink · 2 days ago

Manager, Data Management

United States

Full-time

Remote

Senior Level

10+ years exp

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Clinical TrialsHealth Care

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Serve as the primary internal and sponsor contact for data management questions, issues, or concerns including, but not limited to data collection, data cleaning, data delivery, data reconciliation, database lock and data management activity timelines.

Monitor and work to maintain/improve client satisfaction by ensuring high quality service, communication, and management of source data across the team.

Lead the development, review, and finalization of data transfer and reporting requirements.

Manage resourcing through the assignment of studies, tasks, projects, etc.

Provide oversight of the day-to-day activities to ensure deliverables are met.

Manage the Study Data Specialists and Data Managers

Work across departments to manage customer expectations, improve interdepartmental handoffs, and address escalations within the organization.

Handle both internal and external issue escalations, as needed.

Assist in peer review/QC of department deliverables.

Evaluate current processes for efficiency and quality and make recommendations for improvement.

Direct the process for establishment, review, and adherence of data management processes.

Develop methods/metrics to assist in measuring department performance and productivity.

Interview, hire, train, and terminate staff as needed.

Continuously monitor and evaluate employee performance, quality of deliverables, timeline compliance; provide feedback and guidance when necessary.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical data managementData integrationsSQLSASDocumentationICH guidelinesGCP guidelinesClinical trial protocolsCDISC standardsWordExcelPowerPointProblem-solvingInterpersonalOrganizationalTime managementAttention to detailSnowflakePythonR

Required

Bachelor’s degree in Life Sciences or related field preferred.

Minimum 10 years of clinical data management experience required.

Minimum of 5 years of management/supervisory experience.

Ability to think critically and use good problem-solving skills.

Experience with data integrations and management tools and platforms, such as SQL & SAS required.

Ability to interact with personnel at all levels.

Experience creating and maintaining study specific documentation (data export specifications, requirements, change controls, etc.).

Knowledge of ICH and GCP guidelines.

Understanding and working knowledge of the structure of clinical trial protocols and how they inform study design.

Strong knowledge of CDISC standards.

Strong organizational and time management skills.

Strong computer skills (e.g. Word, Excel, PowerPoint, etc.)

Able to function in a fast-paced work environment with superior attention to detail.

Preferred

Additional knowledge of Snowflake, Python/R nice to have.

Company

Clinical ink

Clinical Ink develops electronic documents recording software for recording source data on mobile devices during clinical trials.

Founded in 2006

Winston Salem, North Carolina, USA

201-500 employees

http://www.clinicalink.com

H1B Sponsorship

Clinical ink 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

Trends of Total Sponsorships

2022 (1)

2021 (3)

2020 (1)