SUMMARY/JOB PURPOSE:

Role provides technical, programming and data management activities at the 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.

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 timelinesTrack 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 initiativesPromote 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 RWSProficiency 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 plusApplied knowledge of CDISC/CDASH/SDTMExperience with handling of external study data is a plusHas 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 requiredUses 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 skillsExcellent 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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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $141,500 - $201,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.