Senior Manager, Clinical Data Management - REMOTE

Proclinical is seeking a Senior Manager, Clinical Data Management for an innovative biotech company. This is a contract role with the opportunity to work remotely.

This individual will be supporting Data Management operational activities for assigned studies and for ensuring compliance with corporate timelines and scopes of work outsourced to service providers.

Must be eligible to work in the US.

Job Responsibilities:

• Serve as Data Manager for assigned studies and coordinate with DM Study Leads and Program Leads to ensure consistent processes and data collection management across all studies.
• Support and execute DM related activities outsourced to DM service provider(s) as well as other external data sources from study start up through study close out and final database lock/transfer while ensuring that all study deliverables and milestones are met with high data quality on time and within budget.
• Provide support for strategic direction, planning, execution, collection, and handling of all clinical data (including but not limited to DMP, CRF design, completion guidelines, edit checks, coding conventions, SAE reconciliation, interim/database lock procedures, data listings) to the highest quality standards while ensuring alignment with other ongoing studies.
• Collaborate in data reviews with cross functional team to the internal data review plan, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
• Actively participate in development, review, and implementation of study documents from other functional groups (e.g., Vendor Oversight and Communication, Clinical Monitoring, Biostatistics, etc.)
• Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
• Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
• Support vendor and technology evaluations, qualifications, and selections, including development of outsourcing strategies for DM services and to the establishment of partnerships with key vendors.
• Contribute to DM RFPs, contract/MSA and budget negotiations, scope changes and invoicing for DM vendor on assigned studies, including identification of potential changes needed as a result of execution of study operations.
• Provide subject matter expertise regarding data collection, cleaning, reporting and transfer for vendor audits for DM services and for other external data providers.
• Help develop SOPs, working practices, DM standards/templates with a focus on CDISC CDASH implementation, policies and Clinical Development process improvement supporting clinical data management activities for best practices and quality data.
• Ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM and other external data providers.

Skills and Requirements:

• Bachelor's degree in a relevant scientific discipline or equivalent
• Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries).
• Experience managing vendors and data management activities from study start up through closure is required.
• Ability to use judgement based upon standards and policies to problem solve, meet timelines and provide alternative solutions.
• Knowledge and experience with various clinical databases, key technologies (e.g., EDC, IVRS/IWRS, central labs, ecg); Knowledge of MRI/PET imaging and data is a plus.
• Knowledge of CDISC standards (CDASH and SDTM) preferred.
• Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines is required.
• Must be willing to travel as required.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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