Remote Associate Director, Data Management bei Pfm

Precision for Medicine is hiring an Associate Director, Data Management to join our team, candidates can work remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

The 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 for data management projects; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and site issues. The Associate Director, Data Management is responsible for cross functional standardization and harmonization, technology and process improvement and resource and business forecasting. Collaborates with executive management on the ongoing development of the Data Management function and facilitates certain initiatives/special projects such as department level training, software and/or systems analysis or implementation.

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

• Oversees the Data Management department in the development of DM processes.
• Involves project and workload resourcing and project management.
• 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, assess and manage timelines.
• Ensure that clinical data management deadlines are met with quality.
• Assess resource needs for assigned projects, as needed.
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• May assist in building clinical databases.
• May conduct database build UAT and maintain quality controlled database build documentation.
• Oversee overall quality of all clinical databases.
• Oversee development of the edit check specifications and manual data review specifications.
• Oversee completeness of data management documentation for the Trial Master File.
• May train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• May review and query clinical trial data according to the Data Management Plan.
• May perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• May run patient and study level status and metric reporting.
• Oversee the development requirements and frequency of report delivery.
• May perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
• May coordinate SAE/AE reconciliation.
• May liaise with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables.
• May 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.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project.
• Oversee and 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.
• Provide technical guidance and advice to key senior leadership on reasonable growth and process goals to assure data quality.
• 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.

Qualifications:

Minimum Required: Bachelor’s degree and/or a combination of related experience.

Other Required: 10 years or more experience in data management in either a CRO/or pharmaceutical or biotech industry. Experience includes having direct reports. Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills. 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. Ability to undertake travel domestically and internationally with overnight stays. Fluency in English.

Preferred: Experience in a clinical, scientific, or healthcare discipline. Dictionary medical coding (MedDRA and WHODrug). Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.). Experience in clinical data management system design and development. Oncology and/or Orphan Drug therapeutic experience. Experience in business development and producing cost estimates. Experience in vendor management.