Job Description

Kelly® Science & Clinical is seeking a Clinical DataManager for a fulltime, contract-to-perm position with a biopharmaceutical client in Seattle, WA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Clinical Data Manager

Full-Time: contract-to-perm, w/full benefit package

Hybrid, Seattle, WA

Relocation assistance is not available.

Summary: Our client, based in Seattle, is a privately held, clinical-stage, fully integrated biopharmaceutical company. Founded in 2017 with a vision to use genetically engineered spirulina - photosynthetic, edible algae – for manufacturing and delivering biologic drugs. Our client uses the spirulina platform for gastrointestinal, airway, and topical delivery of therapeutic proteins, including antibodies, bioactive peptides, enzymes, cytokines, and vaccine antigens. Therapeutic areas of interest encompass infectious diseases, cardiometabolic diseases, inflammatory diseases, and enzyme deficiencies.

We seek an experienced Clinical Data Manager to join our client's team.

The ideal candidate should have extensive knowledge of the clinical data management principles, regulatory guidelines and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.

Primary responsibilities: This role encompasses the management of external Contract Research Organizations (CROs). Act as a Subject Matter Expert (SME) for all data management activities. Provide expert guidance on data management standards, processes, and best practices. Proactively identify risks and contribute to building systems and processes and ensure the highest data quality and integrity across the clinical operations organization.

Key Responsibilities:

• Act as the primary Data Management SME, providing expert guidance on data management standards, processes, and best practices.

• Proactively identify risks and contribute to building systems and processes to ensure high data quality and integrity across the organization.

• Oversee and manage external CROs to ensure adherence to project specifications, timelines, and quality expectations.

• Develop, implement, and refine data management strategies, ensuring efficient data processing, quality checks, and reporting.

• Expertly navigate EDC for data capture, validation, and analysis to uphold data accuracy and efficiency.

• Engage with cross-functional teams under Clinical Affairs and Regulatory Affairs, and IT, to ensure integrated and streamlined data management.

• Lead and contribute to the development, review, and editing of critical data management documents, including but not limited to Data Management Plans (DMPs), Data Transfer Agreements (DTAs), Case Report Forms (CRFs) and other documents.

• Organize, maintain, optimize and audit the internal data repositories and data transfers of the organization to ensure data accessibility, integrity, and compliance.

• Provide comprehensive training and support to internal teams on data management systems, processes, and best practices.

• Proactively identify, troubleshoot, and resolve data-related issues, implementing corrective and preventive measures as necessary.

• Proficiency in both strategic thinking and operational execution is required, including the capability to identify emerging trends and pinpoint the root causes of data discrepancies to proactively address them.

• Ensure strict compliance with industry standards, regulatory requirements, and organizational policies regarding data management and privacy.

Requirements

• Bachelor’s degree in Life Sciences, Biostatistics, Computer Science, or a related discipline, with a preference for advanced degrees.

• A minimum of 7 years of relevant progressive data management experience in the biotech or pharmaceutical sector.

• Demonstrated proficiency and familiarity with multiple clinical data management platforms.

• Proven experience in managing external CROs and effectively collaborating with diverse, cross-functional teams.

• Deep understanding of clinical trial processes, GCP, and regulatory guidelines pertaining to clinical data management.

• Excellent problem-solving, organizational, and communication skills, paired with the ability to work autonomously and manage multiple priorities in a dynamic environment.

• EDC / CRF development experience preferred

Preferred skills and qualifications

• Certification in clinical data management (e.g. CCDM).

• Knowledge of CRF design and analytical capabilities.

• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).

• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

• Firm understanding of data privacy and protection regulations (e.g., GDPR).

• Effective communication and interpersonal skills to collaborate with other teams.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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