Associate Director/Director, Clinical Data Management
The Associate Director/Director is responsible for assigning and overseeing Data Management (DM) operational activities for assigned programs with assigned staff and for ensuring compliance with the corporate timeline(s) and scope(s) of work outsourced to the DM service provider(s) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, training and oversight for all DM services from study start-up through study close-out, final reporting and archiving of all study files.
- Serve as Data Management Program Lead for assigned studies and coordinate with DM Study Leads to ensure consistent processes and data collection management across all studies.
- Serve as point of escalation for both DM staff, internal study teams and external data vendors across assigned programs.
- Lead and manage DM related activities outsourced to DM service provider(s) as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) 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 operational leadership to the 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.
- Oversee and manage 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.)
- Provide oversight to assigned DM(s) to develop study-specific reporting metrics to be reported regularly to cross-functional team on study data status, completeness and cleanliness, conduct internal UAT, coordinating the clinical team’s testing of clinical study databases and database changes to match CRFs according to the protocol, other studies and company standards.
- 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.
- Lead vendor and technology evaluations, qualifications and selections, including development of outsourcing strategies for DM services and to the establishment of partnerships with key vendors.
- Lead development of 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 with regard to data collection, cleaning, reporting and transfer for vendor audits for DM services and for other external data providers.
- 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.
- Manage department personnel and ensure successful study execution and cross-department collaboration with internal and external stakeholders.
- Provide historical data to key stakeholders for other business-related projects/programs.
Education and/or Experience:
- Bachelor’s degree in a relevant scientific discipline or equivalent
- Minimum of twelve years of relevant clinical data management experience and a minimum of 7 years’ experience as a Lead Study Data Manager across phase 1-4 clinical trials
- 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 a plus
- Knowledge of CDISC standards (CDASH and SDTM)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines is required
- Must be willing to travel as required
Competencies and Attributes:
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
- Excellent communication, written and interpersonal skills
- Self-sufficient and able to work within a multi-disciplinary team with minimal oversight
- Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
- Past line management experience required
- Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
- Able to prioritize and handle multiple tasks and studies simultaneously
- Proficiency with MS Word, Excel, Outlook, and PowerPoint
- Knowledge of SAS programming and Visio is a plus
More information about Prothena can be found at the Company’s website: www.prothena.com.
Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.
We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.
Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).
Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.