Precision for Medicine is seeking a highly skilled and dedicated Manager of Data Management to lead the day-to-day operations of our Data Management function. This crucial role involves overseeing and coordinating data management projects, ensuring adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. The Manager will play a pivotal role in establishing a department, developing a department, in resource allocation, personnel development and effective communication within and beyond the department. 

Position Summary:

The Manager, 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 inter-departmental 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.
• 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
• Responsible for creating, revising, appropriate versioning and maintaining data
  management documentation. Oversee completeness of data management documentation
  for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related
  items as needed.
• 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
• Run patient and study level status and metric reporting. Oversee the development
  requirements and frequency of report delivery.
• Perform medical coding of medical terms relative to each other in order to ensure
  medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a projectmanager capacity in support of timelines and data-related deliverables
• Assist with SAS programming and quality control of SAS programs used in the Data
  Management department
• 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
• 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
• Perform other duties as assigned 

Qualifications:
Minimum Required:

• 5+ years’ experience total in Data management, 3 + years in line management
• Bachelors (preferred scientific/science) and a combination of related experience

Other Required:
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of data management tasks and oversight.
• 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

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