Prothena

Associate Director, Clinical Data Management

US-CA-South San Francisco
Job ID
2017-1197
Category
Research & Development

Overview

The Associate Director is responsible for overseeing all Data Management (DM) operational activities for assigned studies ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) 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 and final reporting.

Responsibilities

  • Develop and implement strategic vision for the DM group including processes and procedures for maintaining clinical data with the required QA/QC documentation 
  • Develop RFPs, lead contract and budget negotiations, review and approve Master Service Agreement
  • 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. 
  • Ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM vendors
  • 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 assigned studies, lead and manage all DM related activities outsourced to DM SP 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. 
  • Lead contract reviews, 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 operational leadership to the 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
  • Lead 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
  • Lead the development of the vendor data review plan for each assigned study
  • Execute 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.
  • Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
  • Actively participate in development and review of study documents from other functional groups (e.g. Vendor Oversight and Communication, Clinical Monitoring, Biostatistics, etc.)

Qualifications

Education and/or Experience:

  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of ten years of relevant clinical experience in clinical data management 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
  • Knowledge and experience with various clinical databases, key technologies (e.g., EDC, Scanning/Imaging, IRT and ePRO)
  • Knowledge of CDISC standards (CDASH and SDTM).
  • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines is required
  • Self-sufficient and able to work within a multi-disciplinary team with minimal oversight
  • Knowledge of SAS programming and Visio is a plus
  • 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 core values – courageousness, creativity, selflessness and humor
  • 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
  • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
  • Able to prioritize and handle multiple tasks and studies simultaneously
  • Ability to use judgement based upon standards and policies to problem solve, meet timelines and provide alternative solutions
  • Excellent communication, written and interpersonal skills
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint

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