The Project Data Manager is responsible for the planning, organization and coordination of data management activities supporting clinical trials. This includes, but is not limited to, assisting the Director of Data Management in data management related governance meetings, maintenance of contracts/negotiations, CRO oversight, and the closeout of studies in support of submissions.
The Project Data Manager provides expertise in all data management activities related to the preparation and implementation of clinical trials in the US and internationally. The Project Data Manager works closely with Biometrics and Project Management, Clinical Operations, Regulatory, and other related disciplines to support database development and reporting for all clinical studies.
The main responsibilities of the Data Manager role may include, but are not limited to the following:
- Management and oversight of in house and/or CRO activities, including but not limited to, case report form design, database design, data quality plan, annotated case report forms, edit specifications, etc.
- Management and oversight of data management vendors (Datasets, eCRF, IVRS etc.)
- Manages vendor/CRO relationship, ensures quality and timely deliverables, establishes clear expectations and guidelines, ensures delivery against scope of work in contract.
- Ensures vendor/CRO adherence to data management plans and standards including SOPs.
- Reviews budgets and scope of work from CROs.
- Participates in evaluating new CROs during selection process.
- Participates in vendor evaluation.
- Manages data management deliverables; input to data management project timelines.
- Manages periodic data management team meetings.
- Creates and maintains Data Management Plan documents for assigned studies.
- Ensures study files are routinely organized and accessible during study conduct, and that archives are completed after study closeout.
- Ensures proper filing of DM components in Trial Master File and maintains inspection readiness at all times.
- Ensures clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality.
- Provides accurate and timely data to both internal and external stakeholders to support the business and regulatory requirements of Iterum.
- Provides comprehensive status updates to various stakeholders.
- Designs and reviews ad hoc listings, reports and QC documents to facilitate validation of the data in the database .
- Reconciles data between multiple data sources .
- Ensures data captured in the study database are accurate and complete representations of the data submitted .
- Oversees database release process and data management study close out.
- Collaborates with project manager to ensure continuous improvement and milestones are met.
- Complies with all SOPs, regulatory guidelines, directives and study specific plans pertaining to clinical trial/study process.
- Leads and/or coordinates initiatives to improve processes.
- Reviews existing or authors new functional SOPs and working practices.
- Trains data management staff/consultants.
- Provides data management subject matter expertise.
- Stays abreast of latest developments in data management/EDC, etc.
- Willingness to travel up to 30% of time.
Training and Education :
- Bachelor’s degree or equivalent experience in relevant field (Data Management, Biometrics, etc.).
- 5+ years of clinical development experience in the area of data management, within the pharmaceutical, biotechnology or CRO industries.
- Knowledge of applicable data management standards and regulations.
- Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct.
- Demonstrated global perspective within the context of business needs and impact.
- Highly experienced in Data management of clinical studies.
- Experience of coordinating and planning budgets, people and time management.
- Demonstrated experience in computer skills including Microsoft Word, Excel, etc.
- Capable of handling multiple projects with excellent data management skills.
- Demonstrated ability to interact with and manage CROs.
- Experience with outsourcing models.
- Familiarity with Clinical Data Interchange Standards Consortium (CDISC), MedDRA, and other coding dictionaries.
- Knowledge of FDA, EMEA and ICH guidelines and regulations for data management.
- Knowledge of multiple clinical trial databases (paper based and electronic data capture – EDC).
- Development of policies and SOPs related to data management.
- Proficiency in software applications (electronic mail, electronic calendar, MS windows, general file server use).
- Collaborative and team oriented approach.
- Conscientious and precise in delivery of work even when under pressure.
- Excellent oral and written communication skills.
- Excellent planning, organizing, interpersonal and leadership skills.
- Exhibits a confident and influential approach.
- Makes independent choices and takes responsibility for own actions.
- Recognizes potential obstacles and works to resolve them within set timelines.
- Understands customer needs.