North America Region Manager responsible for driving market growth and establishing presence at a biotech company. Leading regional expansion efforts in the North American market.
About the role
- Manager of Clinical Programming at Kite overseeing complex programming deliverables and supervising clinical programmers. Working on pivotal cancer therapies and ensuring adherence to best practices and standards.
Responsibilities
- May have direct responsibility for supervising and training clinical programmers in the performance of their duties
- Management of programming deliverables in coordination with internal and external cross functional teams
- Perform the execution of programming activities (eCRF and EDC database, integrations, and module connections) for multiple studies of increased complexity and across indications/therapeutic areas
- Provide input into the SOW activities for vendors
- Perform the development and maintenance (migration) of eCRF and EDC database, integrations (e.g., IxRS) and module connections (e.g., Safety Gateway Configuration) based on the protocol and Kite standards
- Oversee creation of operational metadata (including CRF and external) ensuring compliant to Kite standards
- Provide oversight for programming activities which are outsourced to a CRO/Vendor
- Ensure across studies consistency and adherence to standards and governance
- Support Data Review activities (e.g., Review Data Review Plan, develop reporting tool reports, validate reports)
- Perform support of snapshot, database lock activities and deliverables restriction
- Develop, assess, and monitor project priorities/timelines for programming deliverables
- Participate in study team meetings and provide technical expertise with database and reporting applications (e.g., EDC, Tableau, J-Review, Business Objects) and support as needed
- Routinely interface with cross-functional team members
- Ensure that SOPs are properly followed, and documentation is available
- Align with EDC vendor regarding system updates, EDC platform integrations, and issue resolution
- Ensure following programming best practices
- Resolve problems as they arise within defined procedures and escalate, if necessary, at appropriate time
- Represent as internal team leader who decides best course of action
- Participate in CDM, Programming and cross-functional initiatives
- Participate for programming activities during internal audits as well as Health Authority audits
- Align with the department and company strategy and model
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
- Prioritize and delegate, if applicable, effectively study and initiative responsibilities
- Prepare for expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
- Work collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others study team members to meet project deliverables and timelines.
- Build networks to achieve influence with other functions and represent as Programming technical expert
- Participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
- Participate in review, approve and train on department procedures including SOPs and Working Practices
- Actively Participate in programming team meetings when appropriate.
Requirements
- MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Programming OR BS/BA in life science or related discipline and 6+ years of experience in Clinical Programming
- Technical experience in clinical development
- Good understanding of regulatory, industry, and technology standards and requirements
- Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
- Experience with Medidata RAVE including database build, edit check programming, data extraction, migrations
- Understanding of data standards (CDISC, CDASH) in the clinical trial environment
- Experience with SAS programming (recommended)
- Experience with Spotfire and/or J-Review programming (recommended)
- Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- Demonstrate ability to work in a team environment with clinical team members
- Good planning and project management skills as well as vendor management
- Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks.
Benefits
- Discretionary annual bonus
- Discretionary stock-based long-term incentives (eligibility may vary based on role)
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
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