Manages day-to-day operations for a group of data management projects or key functions. May perform the Project Lead role for studies that do not have a clinical component or act as Francise Manager for allocated clients. Provides customer contract and functional, administrative and financial oversight of assigned projects. Monitors entire project life-cycle to ensure smoothness (i.e. creation of electronic edit checks, development of DM Listings, DB go-live, 3rd party vendor data and SAE reconciliation, DB Lock, timelines etc.) May act as the “Account” Manager/CDM Franchise Lead for a portfolio of projects from one or more clients to provide oversight and ensure all tasks are completed accurately, on time and withing budget to meet or exceed client expectations. Acts as primary liaison for project team and client. Participates in internal or client meetings as needed. Oversees risk management for projects/portfolios ensuring adherence to guidelines and process; provides ongoing support and guidance on assessment of project risks to the project members; provides/escalates high-level sharing of risks, concerns, and study success. Participates in business development meetings/activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Helps develop client relationships with oversight from management. Participates in the formation and implementation of strategic department development plans and initiatives. Oversees, reviews, approves the study documents (e.g. DVM) with input from the internal/client teams. Ensures development and maintenance of Data Management project documentation files (e.g. eTMF ongoing reviews) to maintain audit readiness at all times.

Oversee the data management strategy and project plans for collection and integration of all clinical data including case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program. Lead cross-functional, global teams to ensure all aspects of the project plan (from data management trial planning through submission components) are executed on time and with appropriate quality. Serve as a project manager for data management activities and represent global data management for assigned trials. Manage all operational aspects of clinical trials in compliance with GCP regulations, PRAHS policy and Client Company policy. Manage project and timelines across Client programs and studies. Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities. Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel. Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol. Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level. Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion. Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team. Escalate any potential or actual issues in a timely manner and follow issues through to resolution. Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation. Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.

Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization. Responsible for the overall quality and integrity of the database with respect to “Critical to Quality” (CTQ) data points predefined by Clinical and Biostats prior to the start of a study. Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverables. Provides input to the DM related activities associated with regulatory inspections/audits.Provides DM business expertise and consultancy in the selection and use of software systems and vendors. Development and oversight of DM processes and standards and functional leadership.Oversee quality and consistency with Clients strategies and standards across therapeutic areas.Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices. Assesses Clients CRDM needs and areas of improvement and recommends changes to the operating model. Provide strategic DM expertise to Global Clinical InitiativesManagement and oversight of vendor performance. Reviews, assesses and manages DM delivery against KPIs and overall DM performance. Provides input into the contract process for the CRDM vendor. Manages all DM timelines and DM Deliverables for assigned studies. Ensures DM billing is accurate and forwards recommendation to CDM for payment of invoices. Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities. Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house).

Provide asset level clinical data management oversight for assigned projects within a portfolio of clinical studies. Represent Data Management on portfolio process improvement initiatives/strategic initiatives and update to standards. Contribute to bid and proposal development. Review finances across the programs and work closely with the financial analyst assigned. Mentor and train other Data Management team members. Provide expertise in all aspects of the lifecycle of a data managements study. Responsible for achieving interim and final contractual deliverables for projects, with the foresight to provide leadership to anticipate and address potential issuesServes as primary contact for internal and external team members regarding data management activities. Provides oversight and support of data management activities including database and edit check development, data cleaning, vendor data reconciliation, and SDTM deliverables.Develops, plans and oversees timelines for activities from database setup through database lock and SDTM deliverables.Authors documents such as data management plan, interim lock plans, database closure plans and database unlock plans. Tracks milestones, tasks and the data management budget for assigned projects.Participates in Sponsor and third party audits.

Coordinate the Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that the Data Operations deliverables with regard to timelines, quality, and productivity are being met. Provide overall leadership / management for programming, data integration, data processing, medical monitoring and statistical services on a project / program. Provide productivity targets to the project team members. Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements as well as PAREXEL SOPs and study specific procedures. Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity. Act as project leader for data only projects where no PL is assigned as needed.

Reviewed and contributed to the finalization of protocols. Assisted global teams with the design and creation of study specific CRFs. Managed the development and SDTM annotation of CRFs across projects. Provided CRF design status reports. Ensured CRF design activities occurred on time within the approved budget while ensuring UCB standards are followed. Participated in additional standardization projects across projects.

Provided overall leadership / management for programming, data integration, data processing and statistical services on a project / program. Served as liaison with project leadership, other functional leaders and client. Managed the creation and execution of an integrated plan covering all Data Operation deliveries; this included the coordination of dependencies between Data Operation stakeholders (Data Processing, Programming, Biostatistics) either within PAREXEL or at the client Established efficient / effective working relationships with other functional Leaders and experts Project Implementation, Control & Evaluation. Coordinated Data Operations study activities. Provided Leadership and direction to the project team members. Provided productivity targets to the project team members. Ensured the project was completed within budget, schedule, and according to contract specifications. Ensure the project was progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations. Ensured information entered into management systems was accurate and updated on a regular basis. Identified areas of potential problems and provided input into contingency plans. Tracked resources and actual time spent on each project task for all team members to evaluate project progress and productivity.

Served as Project Lead on a standalone contracts for Data Management. Served as Functional Team Lead for Data Management on full service contracts. Ensured the launch, delivery and completion of all Data Management activities according to contractual agreement, relevant SOPs, guidelines and regulations. Managed changes in scope, budget, revenue recognition/forecasting and participation in monthly internal project reviews. Participate in the development of CRF’s as needed as well as QC of CRF annotations. Participated in, and presented at internal, customer, third-party and investigator meetings. Monitored and communicated project progress to the customer and project team including use of project status reports, and tracking tools/metrics. Assisted in the development and delivery of applicable departmental training, technologies, SOPs, processes and procedures.

Served as a lead data manager for clinical trials. Reviewed all study related patient information captured during the conduct of the clinical trial. Served as the project liaison for the different functional groups. Managed changes of scope, budget, revenue recognition, and participation in monthly internal project reviews. Assisted in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer and IVRS vendors. Coordinated user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import / export programs and medical coding. Provided project specific training for project team in project specific requirements. Participated and presents at internal, customer, third-party and investigator meetings.

Designed, developed and implemented study planning documentation with the collaboration of clinical, data and project management team. Responsible for creating and maintaining CRF annotation used for studies. Requested updates or modifications to standards library as needed. Managed the initiation of database build and testing. Responsible for writing and testing edit checks. Maintained study objectives and interact with project team to ensure a quality database. Served dual roles as project manager and data manager for projects as needed.

Ensured that the data captured and stored in the clinical study database is accurate and complete. Worked on project teams and comply with SOPS, regulatory guidelines, and directives, and study specific plans pertaining to collection, review, and management of clinical study data. Developed and implement study specific data management plans in collaboration with other functional groups for the client. Contributed to the design of data entry screens and case report form. Write and test edit check specifications.

Programmed and tested consistency checks. Validated CRF data for several projects. Trained new staff on data management project tasks. Assisted with the creation of data management plans. Performed manual review of data. Assisted with database testing and validating. Resolved data issues by issuing data clarification forms to sites.