Project Data ManagerApply Now
Website Syneos Health
- 💡 Mid-Level 💡
- 🇺🇸 Anywhere in the U.S. 🇺🇸
Ensures the contracted Data Management for clinical studies are carried out by the Company in accordance with the executed contract and the customer’s expectations.
- Acts as Project Leader on a stand-alone contract (“project”) for Data Management, to include:
- Primary customer contact for all contracted Data Management;
- Direct liaison with Finance and Contract department on required matters (e.g., invoicing, contract changes).
- Acts as Functional Lead for Data Management on full service contracts to include:
- Primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on ‘full service’ contracts;
- Liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes).
- Ensures launch, delivery and completion of all Data Management according to the contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
- Manages changes of scope, budget, revenue recognition, and participation in monthly internal project reviews.
- Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
- Plans, manages, and requests resource as required for assigned studies.
- Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with the project team to actively influence data collection.
- Develops and maintains:
- Data Management Plans;
- Project Management Plans (for stand-alone contracts only);
- Communication Plans (for stand-alone contracts only);
- SAE Reconciliation Guidelines
- Quality Plans; and other plans as delegated/required.
- Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors.
- Maintains documentation on an ongoing basis and ensures that all filing is up to date.
- Regularly reviews project files to ensure that all filing is up to date.
- Manages the database freeze and lock processes and procedures.
- Ensures that all applicable documents and databases (data sets) are archived or returned to the customer appropriately.
- Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.
- Provides project-specific training for:
- CRAs to be able to train site staff to use EDC system;
- site staff to use EDC system;
- project team in project specific requirements.
- Manages Quality Control (QC) process for checks of CRF database versus Case Report Forms (CRFs) and Data Clarification Forms (DCFs):
- specifies required CRF database listings;
- Summarizes results and resolves issues from checks of such listings against CRFs and DCFs.
- Schedules and requests data transfers/imports/exports to/from CRF/eCRF database and associated databases.
- Reviews and approves
- Project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required;
- Specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;
- Output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.
- Participates in, and presents at internal, customer, third-party, and investigator meetings.
- Plans for and creates necessary documentation to support internal and external audits; participate in such audits.
- Participates in the development of departmental technologies, SOPs, processes, and procedures.
- Develops and delivers applicable data management departmental training.
- Trains and mentors data management staff.
- Contributes to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepares input for, and participates in proposal bid defense meetings.
- Maintains proficiency in Data Management systems and processes through regular training. Takes the opportunity to network with colleagues for new and/or repeat business.
- BA/BS in the biological sciences or related disciplines in the natural science/health care field.
- Moderate clinical data management experience or an equivalent combination of education and experience.
- Experience in Clinical Data Management practices and relational database management software systems.
- Demonstrated staff leadership skills. Contract Research Organization (CRO) experience preferred.
- Direct exposure to Oracle Clinical, Rave, or Inform systems.
- Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
- Effective oral and written communication skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
- Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
- Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.