Shire Jobs

Reference #: JR5693 SUMMARY/JOB PURPOSE: Provide oversight for the execution of data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, smaller studies. Will support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring.

Essential Duties And Responsibilities:

• 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
• Lead the planning and execution of data management activities on assigned studies
• 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.
• Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
• 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
• Lead electronic submission activities for Data Management as appropriate.
• Participate in selecting outsourcing partners for assigned studies including: Input to Request for Proposal (RFP) Review proposals Participate in evaluation/audits and capabilities presentations 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, * PhD in related discipline and a minimum of 2 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 and/or combination of experience and education/training.
• A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
• A minimum of 4 years in a project leadership role
• Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVR /IWRS) is preferred.
• Demonstrated experience leading data management teams is preferred

Knowledge/Skills:

• 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
• Expertise in CDASH/CDISC standards preferred.
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• 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:

• Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues
• Works independently and consults with management on decisions affecting project delivery as appropriate
• Drives the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations will cause delays in program schedules and may result in the allocation of additional resources.
• Regular inter-organizational and outside contacts on routine matters.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• 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 severalU.S. geographic markets, and we pay differently based on those defined markets.  The base pay range for this positionis $143,000 - $203,000 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 includ