Sr. Clinical Systems (Medidata Rave Project Manager) Programmer Ii

SUMMARY/JOB PURPOSE:
Role provides technical support as needed for Medidata RAVE and Oracle Inform system functionality. Maintains program/project level perspective; focuses and communicates effectively as the SME on technical and functional EDC programming and data management issues, activities, timelines, and deliverables.
** This role requires a 3 day onsite presence working at our King of Prussia, PA location or Alameda, CA location. Relocation provided for qualified candidates.
Essential Duties And Responsibilities:

• Must be able to program complex report using SAS
• Manage group of vendor SAS Programmers
• Ability convert non-technical requirements to technical specification or vice versa
• 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
• Perform user and site administration to include site set up and assignment of roles, permissions, and eLearning requirements
• Verify completeness of study build deliverables prior to release
• Perform peer review for the studies built by other programmers
• Maintain all required Clinical Systems study documentation
• 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 system upgrades.
• Provide technical assistance and training to technical / non-technical personnel.

Supervisory Responsibilities:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:

• BS/BA degree in related discipline and a minimum of nine years of related experience; or,
• MS/MA degree in related discipline and a minimum of seven years of related experience; or,
• PhD degree in related discipline and a minimum of two years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of nine years of related experience or the equivalent combination of experience and education/training.
• A minimum of four years of clinical data management experience is also required in the bio/pharmaceutical industry or clinical trials.

Knowledge/Skills:

• Database programming experience is required.
• Proficiency in computer skills across multiple applications.
• Minimum two to three years current database programming experience designing studies and data validation programming in Medidata Rave and/or Oracle Inform required.
• Applied knowledge of Medidata suite of applications (e.g., Medidata Coder, Lab Administration Module, and Safety Gateway) is a plus.
• Expertise with reporting tools; Business Objects, Cognos, and J-Review
• Working knowledge of SAS is a plus
• Applied knowledge of CDISC/CDASH/SDTM
• Experience with handling of external study data is a plus
• Excellent verbal and written communication skills, as well as interpersonal skills are required.
• Has a working knowledge of relational database design and FDA regulation 21 CFR Part 11

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.

Working Conditions:
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 $136,250 - $193,250 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.