1. Oversees the execution and implementation of detailed project plans in concert with stakeholders. 2. Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met. 3. Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed. 4. Works closely with business analysts, technical professionals, end users and project stake holders during the requirements, solutions design and implementation phases to develop detailed project plans for implementation. 5. Works on risk assessment, communication planning, development of performance metrics, and project entry criteria. 6. Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion. 7. Manages client expectations and provides issue/risk identification and escalation pathways. 8. May supervise the implementation team of cross-functional project and technical resources. 9. Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff. 10. Resolves complex project issues that involve representatives from multiple organizations. 11. Complies with standard policies and procedures. 12. May supervise and train junior project managers. 13. May perform other duties as assigned.

Required Skill/ability 1:  Demonstrated experience working as a Data Manager for an industry Sponsor or CRO or ARO managing FDA and/or EMA-regulated clinical trials. Extensive experience in all facets of study start-up/activation, on-going management of multiple protocols, study close-out, and regulatory submission. Ability to manage and lead a team. 

Required Skill/ability 2:  Demonstrated experience with EDC, CTMS, and eTMF systems. Knowledge of 21 CFR Part 11 requirements. 

Required Skill/ability 3:  Demonstrated experience in creating database specifications and building studies in one or more Electronic Data Capture (EDC) systems (e.g. Medidata Rave, Oracle InForm, IBM Clinical Development, Medrio, REDCap, etc.)

Required Skill/ability 4:  Comprehensive technical knowledge of FDA and EMA clinical data standards and regulations, data management practices (GCDMP), and medical coding (MedDRA, WHODrug). Knowledge of SDTM data standards (CDASH, SDTM, ADaM).

Required Skill/ability 5:  Demonstrated experience with project management and computer validation projects. Professionalism, maturity, good judgment, and ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access. 

Preferred Education:  Master's degree preferred. Cerfied Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Proven experience with eCTD data submissions, FHIR, and data integraon from EHR systems (e.g. Epic) & other eSource data sources (Direct Data Capture, eCOA/ePRO, etc.).

Work Week:  Standard (M-F equal number of hours per day)

Posting Position Title:  Project Manager

University Job Title:  Assistant Director of Clinical Data Management

Preferred Education, Experience and Skills:  Master's degree preferred. Cerfied Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Proven experience with eCTD data submissions, FHIR, and data integraon from EHR systems (e.g. Epic) & other eSource data sources (Direct Data Capture, eCOA/ePRO, etc.).

Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.

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