12-month, remote contract with potential to extend supporting west coast biotech company
As the Senior Clinical Data Management Lead consultant, you will be responsible for providing data management activities across one or more clinical development programs. The Sr CDM Lead will serve as a core team member in the Clinical Study Team and is accountable for planning, coordination, and timely delivery of complete, high quality, and reliable clinical trial data.
The Sr CDM Lead is responsible for ensuring compliance with corporate timelines, all regulatory standards, and the scope of work herein. This position will report to the Head of Clinical Data Management.
Your goals will include:
- Demonstrate leadership and operational knowledge in the planning and execution of CDM deliverables across one or more programs at a departmental level
- Support Senior Leaders to oversee CDM Vendor performance. Review, assess, and manage DM Vendor performance against KPIs, budget health, and overall quality/timeliness of study deliverables. Oversee vendor timelines and critical milestone deliverables for assigned studies
- Serve as the main point of escalation for critical DM risks/issues across departments and Vendors
- Work with Senior Leadership to prioritize deliverables across study programs and manage workloads/deliverables across CDM
- Provide guidance, leadership, and supervision to DM Team working on the study (CRO or in-house)
- Mentor junior CDM colleagues at all levels, providing ongoing feedback and career development guidance
- Ensure DM Vendor billing is accurate and review/approve budgets and changes in budget scope
- Drive SOP development and serve as key contributor/approver for departmental SOPs and associated templates/forms/trainings
- Communicate and collaborate effectively with all study level team members
- Understand therapeutic areas, indications, and program specific data capture standards and standards
- Ensure departmental SOP compliance and compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with CDM vendors via regular process auditing. Ensure internal CDM project documentation is in an inspection-ready state across one or more programs
- Maintain an awareness of external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM
- Use clear judgment to tackle problems and identify issues and propose solutions; be proactive, rather than reactive
- Lead CDM related activities associated with regulatory inspections/audits for assigned studies
- Lead CDM activities related to Trial Master File (TMF) compliance
- Drive standardization of Clinical Data Management processes and process improvement and efficiency
- Lead vendor and technology (e.g., EDC) evaluation, qualification, and selection efforts
- Lead RFP development and contract negotiation on behalf of DM
- Bachelor's Degree in a scientific subject area or health related field
- Minimum of 8 years in a pharmaceutical/biotechnology or CRO setting; global/international experience is a plus.
- Experience supporting Phase I to III clinical trials
- Knowledge and experience in EDC (Medidata Rave expertise is a plus), key technologies (e.g., IXRS) and industry standards including regulatory regulations (21 CRF Part 11), ICH-GCP guidelines, and CDASH/CDISC with understanding of Basic, SAS, SQL and/or other clinical programming applications.
- Proficiency in computer applications and time management tools (e.g., Microsoft Office applications)
- Strong interpersonal, organizational, and communication (verbal and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Willingness to travel if required
- Ability to prioritize workload and meet deliverables, demonstrate effective use of time, and handle multiple assignments simultaneously
- Capability to actively identify project challenges and risks and propose appropriate and strategic solutions to issues.
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