Senior Clinical Data Manager

Senior Clinical Data Manager

W2 Contract

Salary Range: $166,400 - $187,200 per year

Location: South San Francisco, CA - Remote Role

Job Summary:

We are seeking to recruit a Senior Clinical Data Manager Contractor. The Senior Clinical Data Manager Contractor will work in an outsourced data management model. He or she will develop a strategy, lead data management activities, and interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standards and study-specific procedures.

Duties and Responsibilities:

• Serve as a data management expert and, if assigned, be the CDM lead for assigned clinical studies on multidisciplinary project teams.
• Deliver high-quality data for analysis and study milestones.
• Reviews protocols from a CDM perspective and provides functional-expert feedback.
• Review and approve key clinical data management deliverables generated by a DM vendor, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements.
• Manage/oversee study setup, testing, and system validation for new studies in partnership with the DM vendor.
• Perform / Oversee data cleaning activities executed by the DM vendor and ensure protocol-specified guidelines are applied to the review and cleaning of clinical data.
• Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities.
• Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and the project team.
• Monitor vendor performance to ensure timelines and data quality standards are met.
• Ensure compliance of clinical data management processes with applicable regulations and guidelines.

Requirements and Qualifications:

• BA/BS or higher, preferably in math, science, or a health-related field, with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials
• At least 5 years of overall experience acting as a study lead data manager. Experience in all study phases, including early phase and dose escalation studies, is greatly preferred.
• CNS/Neurodegenerative trial experience is greatly preferred
• Comprehensive experience working with clinical database systems
• Working knowledge of CDISC, including CDASH, TAUG, and SDTM, as well as data privacy regulations, e.g., GDPR
• Able to work in a fast-paced and dynamic environment while effectively managing multiple projects, which may have changing priorities
• Able to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors
• Clear verbal and written communication skills
• Strong analytical and problem-solving skills

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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