Penfield Search Partners
Contact: Linda Aronova 646.882.9021 firstname.lastname@example.org
The Associate Director/Director of Clinical Data Management will lead and manage the CROs, provide hands-on Clinical Data Management (CDM) support to companys programs as well as contribute to the development of companys CDM function. The title will be commensurate with experience. The individual will be responsible for managing, leading, and overseeing all CDM planning and operational activities to meet corporate objectives, budgets, and timelines.
The AD/Director will collaborate closely with cross-functional teams including biostatistics, clinical operations, clinical development, statistical programming, translational research, and other functions. The individual is responsible for working closely with external vendors and providing oversight for outsourced data related activities. They will work with the Head of Biometrics to build and lead the CDM function, design and drive overall visions for the function, including strategical direction, process and standards, infrastructure, systems, vendor selection, innovative technology, and talent development. The individual may be responsible to manage junior and senior Clinical Data Manager(s).
- Oversees (sometimes leads) the data management of Phase 1 through Phase 4 clinical trials in large or complex development program(s).
- Oversees the process to identify, evaluate and select CROs, vendors and technology for CDM activities.
- Provides technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose.
- Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials.
- Represents Data Management and promotes productive collaboration with other functions (e.g., Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Translational Science, Project Management, Regulatory, QA, and IT) to ensure proper alignment around data management activities & deliverables, operational excellence, compliance with regulations, policies, procedures, and clinical objectives.
- Supports cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks. Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams and studies.
- Works with the Head of Biometrics to establish CDM processes and procedures including SOPs to ensure highest data quality/integrity/security and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
- Works with the Head of Biometrics to manage departmental budget and execute resource planning across multiple projects.
- Works with the Head to Biometrics to provide oversight and guidance, as well as establish key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance.
- Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review if needed.
- Uses scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution.
- Reviews and contributes to clinical protocols and amendments, study manuals, and other study conduct related clinical documents; review clinical data according to these documents.
- Bachelors Degree Required (Masters Degree preferred) in the scientific/healthcare subject area, e.g., life sciences, computer sciences, scientific related field.
- Minimum 10 years of CDM experience in biotechnology or pharmaceutical industry with vendor oversight experience or CRO setting, including study lead experience; global/international experience a must; with at least 5 years of line management experiences.
- Attainment of Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management is preferred.
Knowledge, Skills and Abilities:
- Experience with clinical trials in Gastrointestinal/Rheumatic Disease TA area, immunology or/and biomarker data management is a plus.
- Experiences of all stages of a clinical trial and vendor oversight.
- Experiences of managing and mentoring clinical data managers are preferred.
- Extensive experience managing CROs and other data vendors.
- Advanced knowledge and hand-on experience of CDM processes, EDC & CDMS systems, integration between vendor or reporting systems, database programming, quality management and technology advance in the field of CDM.
- Solid understanding of overall drug development process with early and late phase clinical trials.
- Proficient in CDASH and CDISC standards, ICH guidance, GCP standard 21 CFR Part 11.
- Proficient in current MedDRA and WHO Drug dictionaries.
- Excellent verbal and written communication skills and the ability to work well in a team.
- Experiences in designing and leading cross-functional projects with internal partners or CROs.
- Logical thinking, attention to details and accuracy, good organizational skills, and outstanding problem-solving abilities and influencing/negotiation skills.
- Ability to prioritize and adapt quickly to changing business conditions with a positive attitude.
- Ability to prioritize workload and meet deadlines, demonstrate effective use of time, and handle multiple priorities simultaneously.
- Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness in a dynamic and growing organization.
- Willing to travel if required.