Precision Medicine Group is hiring a
Manager/Associate Director

Summary

Join Precision Medicine Group as Manager or Associate Director, Data Management to oversee day-to-day activities of the Data Management function, manage data management projects, and provide technical and operational guidance.

Requirements

• 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
• 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

Responsibilities

• 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
• 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
• 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

Preferred Qualifications

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA)

Benefits

• Health, dental and vision insurance
• 401(k) plan with company match
• Flexible PTO policy
• Professional development opportunities