At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Position Summary:
Develop strategy and lead Clinical Data Management (CDM) and Clinical Programming (CP) activities for all MannKind studies. Ensure the completeness and integrity of the clinical data from initial planning and design of studies to close-out and delivery of final data. Act as the point of reference for clinical data collection and data quality related activities to study team members, external vendors, CROs, consultants, Information Technology, Quality Assurance, Regulatory, and MannKind's Senior Management team.
Principal Responsibilities:
- Use industry knowledge and experience to ensure the delivery of high quality, customer focused clinical data for multiple, concurrent MannKind studies.
- Responsible for all project and study related CDM/CP activities from inception to close-out. These activities include but are not limited to:
- Determination of data capture methods (e.g. eCRF, ePRO, eClinical Outcomes Assessments (eCOA), Healthcare Related Questionnaires, IWRS data, lab data, biomarker data, central adjudication activities, etc.)
- Development of study documents, such as translation of protocol to annotated CRFs, Data Management Plans, Medical Coding Plans, Risk Management Plans, Randomization Plans, Trial Supply Management Plans (where applicable), Data Monitoring and Validation Plans, Protocol Deviation Plans, Data Quality Release Reports, Statistical Analysis Plans and Clinical Study Reports.
- Responsible for data-related study startup and build activities, such as eCRFs, EDC database design including oversight of User Acceptance Testing (UAT), data validation specifications, custom programming, reporting tool development, electronic safety data capture and Data Transfer Plans and programs.
- Lead data review, data cleaning and reconciliation activities. Review query and data entry reports for performance trends. Lead database lock and data transfer activities.
- Responsible for delivery of high-quality data (SAS datasets, SDTM datasets, raw data, operational data, etc.) for interim and final close-out of studies
- Ensure completion, lifecycle management, and archival of all CDM/CP documentation.
- Define and meet timelines for dataset and operational deliverables to meet key milestones.
- Participate in the vendor selection process. Responsible for the oversight of CRO/vendor CDM and CP activities and deliverables. Oversee training of CRO and site personnel, conduction of meetings, as well as accountability and performance related to data output.
- Lead data archival efforts, including development and maintenance of clinical data repositories for compliant data storage.
- Review data and operational trends, outcomes and metrics to engage and drive Study Team discussion and action.
- Conduct in-stream data trend analysis and patient profiles in support of data quality and integrity, including protocol compliance and deviation monitoring, safety monitoring and targeted patient recruitment accuracy.
- Address study and site related data issues with key stakeholders and vendors. Conduct root cause analysis, corrective and preventative actions, routes of escalation and follow-up activities.
- Contribute to the design and development of study-related documents including but not limited to protocol and protocol amendments, investigator brochures, Safety Monitoring Committee charters, laboratory manuals, pharmacy manuals, data reporting tools, case report forms, newsletters, and patient-facing materials.
- Provide operational oversight of data deliverables as it relates to site monitoring staff participating in the study.
- Develop policies, SOPs, work instructions, CDM/CP standards and clinical development process improvements relating to data operations.
- Participate in special projects or process improvement initiatives. Represent CDM on cross-functional study teams and cross-functional project teams, including Clinical Operations, Safety, Medical, Programming, and Biostatistics.
- Coordination and oversight for all clinical systems, as needed.
- Forecast budgetary needs and monitor expenditures against contract, departmental and project-specific budgets. Define, forecast and manage CDM/CP resources.
- Represent CDM/CP capabilities and/or needs to stakeholders.
Minimum Qualifications:
- Bachelor's degree in science or related discipline. Advanced degree preferred.
- Minimum of 12 years of experience in pharmaceutical/biotech industry in a clinical data management role
- Thorough and broad knowledge of data management processes, including EDC and interactive web response system (IWRS) experience
- Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
- Experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
- Thorough and broad knowledge of data management processes
- Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
- Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials.
- Excellent attention to detail with a strong professional commitment to high quality work.
- Ability to handle multiple studies simultaneously.
- Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Demonstrated ability to work successfully in a nimble fast-paced matrixed environment.
- Vendor management experience is critical
- Excellent interpersonal skills including developing relationships at all levels in an organization to influence business objectives.
- Commitment to working collaboratively and to building team and company culture.
- Analytical, strategic thinker with good problem-solving skills.
- Articulate and persuasive in both scientific and business forums.
- Effective written and verbal communication skills.
- Self-organized, self-directed, and highly motivated with strong critical thinking and analytical skills.
- Highly collaborative team player capable of collaborating with individuals at all levels (individual contributors to executives), across the business.
- A confident and strategic individual who can think out loud and "brainstorm" in a collegial manner.
- An innovative, data-driven, and effective person with a "can do" attitude.
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