Precision For Medicine

Data Scientist

• Responsible and manages all aspects of the clinical trial data management process
• Ensure that clinical data management deadlines are met with quality
• Oversee project data entry process including development of data entry guidelines
• Conduct database build UAT and maintain quality controlled database build documentation
• Perform quality control of data entry
• Train clinical research personnel on the study specific CRF
• Review and query clinical trial data according to the Data Management Plan
• Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity
• Identify and troubleshoot operational problems and issues
• Participate in the development and maintenance of Standard Operating Procedures (SOPs)

Clinical Data Manager II/Senior Clinical Data Manager

• Primary Data Management (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. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses 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
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May 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
• 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 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
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and 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
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• Perform other duties as assigned

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s)
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assess and manage timelines
• May develop CRF specifications from the clinical study protocol
• Conduct database build UAT and maintain quality controlled database build documentation
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation
• 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
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaise with third-party vendors such as external data and EDC vendors
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

Senior Clinical Data Manager

• Primary Data Management (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. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses 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
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May 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
• 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 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
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and 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
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Clinical Data Manager II / Senior Clinical Data Manager

• Primary Data Management (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.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• May perform quality control of data entry.
• 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.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May 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.
• 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 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.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings.
• May review Request for Proposals (RFP), proposals, provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Trains and 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.
• May present software demonstrations/trainings, department/company training sessions, present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Clinical Research

• Leading pre-award feasibility projects
• Provide detailed pre-award support to operational strategy and business development teams
• Provide feasibility analysis and input for pre-award RFPs
• Provide enrollment modelling(s) for agreed study strategy(ies)
• Undertake feasibility site outreach for pre award opportunities
• Support and/or attend BDM and client calls
• Apply process, templates and delivery standards for feasibility pre-award
• Leading post-award feasibility projects
• Provide guidance for post-award, rescue and standalone feasibility in alignment with study and client requirements
• Manage feasibility project team in all aspects pertaining to the conduct of the feasibility
• Present feasibility strategy at KOM and provide regular updates to sponsor
• Conduct the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Support Business Development in client meetings and bid defense presentation

Feasibility Manager – Post Award

Compliance

• Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics
• Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients
• Review and direct the development of analytical and clinical protocols, technical reports and other company documents
• Identify and collaborate with external thought-leaders and technical experts required to support research and development
• Review and edit regulatory communication, submission, timeline and approval requirement documents
• Apply quality systems expertise to guide clients towards successful readiness to market products
• Generate new business through your own network
• Work in conjunction with management to design and develop customized program recommendations
• Lead workshops and conference curriculums in regulatory science for in vitro diagnostics
• Advise on work orders, change orders, master service agreements and other documents
• Collaborate with business development account management team

Clinical Data Manager II/Senior Clinical Data Manager

Clinical Data Manager II/Senior Clinical Data Manager

Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Feasibility Manager – Post Award

Director, IVD Regulatory Consulting