Manager/Associate Director, Data Management

*This position is 100% remote, but the preference is to have someone on the east coast*

Position Summary:

The Manager or Associate Director, Data Management manages the day-to-day activities of the Data Management function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for data management projects; coordinates interdepartmental and client communication and helps resolve administrative, personnel, and site issues. In addition, manages all aspects of the clinical trial data management process from study start up to post database lock for Electronic Data Capture (EDC) and paper CRF trials. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

• DM Oversight of sponsor programs. May be the primary DM contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity,
  responsiveness, and that tasks are performed in a timely manner for all studies for these clients. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Oversee development of the edit check specifications and manual data review specifications
• Run patient and study level status and metric reporting. Oversee the development requirements and frequency of report delivery.
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management, database management, applications development and SAS programming activities
• Provide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior management
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• Reviews Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Requires some travel
• May perform other duties as assigned

Maybe Required (But Rare):

• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

Qualifications:

Minimum Required:

• 5+ years of experience for a Manager role or 10+ years of experience for the Associate Director role in data management in either a CRO/or pharmaceutical or biotech industry or equivalent relevant experience and/or demonstrated competencies.
• Bachelors and/or a combination of related experience

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong leadership and interpersonal skills
• 1+ years of leadership experience

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Oncology and/or Orphan Drug therapeutic experience