Clinical Data Manager

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Assist in data management activities that support clinical studies throughout all phases of clinical drug development.

• Facilitate cross-functional evaluations of electronic Case Report Form (eCRF) content and aid in the development of eCRFs.

• Support the construction of databases, including the examination of edit check specifications and user acceptance testing.

• Oversee vendor data collection, coding, and cleaning by monitoring study metrics and conducting targeted data reviews.

• Manage database lock procedures and archive study data effectively.

• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance, Contract Research Organizations (CROs), laboratories, and additional vendors.

• Create cross-functional internal data review plans, coordinate data cuts/transfers, and carry out data assessments.

• Evaluate CRO data management strategies, CRF completion guidelines, edit check specifications, external data transfer specifications, and other relevant study documents.

• Advocate for data management by communicating requirements, strategies, timelines, and deliverables in both internal and external meetings.

• Engage in drafting and/or reviewing project timelines to ensure deliverables and milestones are achieved.

• Analyze clinical protocols/amendments, clinical study reports, statistical analysis plans, and associated documents.

• Prepare for Good Clinical Practice (GCP) inspections.

• Exhibit alignment with company values.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s or Master’s degree in a scientific discipline is required; a Master’s degree or equivalent is preferred.

• A minimum of 8 years of relevant experience in a CRO, pharmaceutical, biologics, or biotechnology company.

• Experience in overseeing studies/vendors.

• Familiarity with global studies utilizing an outsourced CRO model.

• In-depth knowledge of Data Management processes, including the efficient design and construction of an EDC data management system and other Clinical Trial/Data Management Systems.

• Understanding of regulations and industry-standard data formats, such as CDISC SDTM and CDASH.

• Experience with EDC data management systems.

• Knowledge of ICH GCP and a general awareness of industry practices and standards.

• Familiarity with regulatory requirements and expectations for clinical data systems, including 21 CFR Part 11.

• Highly motivated and adaptable, with exceptional organizational and time management abilities.

• Capability to work autonomously as well as collaboratively within a multi-disciplinary team.

• Proficient in Microsoft Word and Excel.

• Preferred: Experience with Medidata Rave EDC.

• Preferred: Experience utilizing standardized medical terminology, such as MedDRA and WHODrug.

• Preferred: Previous experience working for both a Sponsor company and a CRO.

• Preferred: Experience in early phase clinical trials.

• Strong interpersonal and communication skills, both verbal and written.

• Excellent problem-solving and organizational abilities.

• Proven capacity to work independently.

• Self-motivated, proactive, and resourceful.

• Strong capability to manage managers and/or individual contributors.

• Exceptional analytical and problem-solving skills.

• Superior communication skills with a diplomatic approach.

• Proven ability to lead cross-functional initiatives related to Data Management.

• Demonstrated proactivity in minimizing and mitigating risks independently.

• Proven ability to conduct root cause analysis across functions for business problem-solving and process improvement development.

• Outstanding presentation skills for both internal and external audiences.

🏝️ Benefits

• Comprehensive benefits package, which may include incentive compensation, restricted stock units, medical coverage, and other benefits based on the position.

• May require travel.