Senior eClinical Solutions Manager (Clinical Programmer / Data Management)

SUMMARY/JOB PURPOSE:

Role provides technical, programming and data management activities at the oncology program level. From Study Startup up through regulatory submission. Will support CDM Process improvement initiatives. Maintains program/project level perspective, focus, and communicate effectively as the SME on technical and functional EDC programming and data management issues, activities, timelines, and deliverables.

*** Please note this role is an onsite role that can report to the Alameda, CA office or King of Prussia, PA office.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate in EDC design requirements development in collaboration with Study Lead Data Manager and the wider study team.
• Support development of and updates of global library objects as appropriate according to best practices and new standards.
• Design/create and test clinical databases including forms, folders, matrices, data dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard and custom reports.
• Verify completeness of study build deliverables prior to release.
• Perform peer review for the studies built by other EDC programmers.
• Maintain all required Clinical Systems study documentations.
• Provide EDC technical support to facilitate study timelines and deliverables.
• Manage timely-quality deliverables for the study teams for assigned protocol/study(s).
• As SME is responsible to provide escalation of study-specific functional issues, tool/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting.
• Provide support for EDC platform system upgrades.
• Provide technical assistance and training to technical / non-technical personnel.
• As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines.
• Ensure all Data Management study documents are developed and archived.
• Establish and lead the Data Working Group (DWG) for assigned study.
• Develop and maintain Data Management timelines
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting.
• Effectively identify and mitigate risks to Data Management deliverables.
• Identify and resolve data handling related issues.
• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
• Direct and oversees activities of Data Management staff assigned to studies and tasks within projects.
• Perform project level resource management in conjunction with CDM Management.
• Review project scope of work documentation.
• Provide oversight of vendors providing Data Management services.
• Develop and execute study specific training of staff within a project.
• Lead or participate in CDM process improvement initiatives
• Promote and be an advocate for CDM internally and externally.
• Direct the activities and hold accountable junior data managers and/or data review teams.

SUPERVISORY RESPONSIBILITIES:

• No direct reports

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 9 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 7 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 9 years of related experience or the equivalent combination of experience and education/training.
• A minimum of 7 years of clinical data management experience is also required in the bio/pharmaceutical industry or clinical trials.
• Experience with Electronic Data Capture (EDC) is required and experience with IVRS/IRT is preferred.

Knowledge/Skills:

• Database programming experience is required.
• Applied knowledge in IRT integration using RWS
• Proficiency in computer skills across multiple applications.
• Minimum 5 years current database programming experience designing studies and data validation programming in Medidata Rave is required.
• Proficiency in Medidata suite of applications (e.g., Medidata Coder, Lab Administration Module, RAVE Safety Gateway, tSDV and Grants Manager) is a plus.
• Expertise with reporting tools; Business Objects, Cognos, and J-Review, BI (Spotfire, Tableau, etc.) is a plus.
• Working knowledge on SAS is a plus
• Applied knowledge of CDISC/CDASH/SDTM
• Experience with handling of external study data is a plus
• Has a working knowledge of relational database design and FDA regulation 21 CFR Part 11.
• The ability to problem solve and have people/project leadership skills.
• Knowledge of GCP is essential.
• General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Demonstrated Data Management Project Management skills
• Excellent verbal and written communication skills and interpersonal skills are required.

JOB COMPLEXITY:

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.

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