Executive Director, Clinical Trial Management Systems CTMS eTMF(Remote)
Precision For Medicine
Denver Colorado
United States
Executive Management
(No Timezone Provided)
Position Summary
This position reports to the SVP Global Business Operations, and collaborates with the Chief Information Officer (CIO), as well as clinical executive leaders. The Executive Director, CTMS & eTMF will create strategic and transitional plans to support effective clinical trial management systems and electronic Trial Management Filing systems for Precision for Medicine. The Executive Director will be responsible for the development of a strategic direction for technology development and implementation to drive efficiencies. This individual will also highlight clinical informatics opportunities and requirements for global clinical trial operations and resolution of outstanding issues.
The Executive Director will have a solid understanding of the health care sector and familiarity with electronic health record systems including the standardization of data and processes. Advanced knowledge of contemporary information management, health and business processes, technologies and application and their application in solving complex health, business and operational problems.
Essential functions of the job include but are not limited to
- Develop and maintain a 3-5-year CTMS Strategic Roadmap outlining the timing and sequencing for delivering key business capabilities and enhancements to the CTMS to support tri-institutional business needs over the long term.
- Create and implement change management strategies and plans that maximize employee adoption and usage and minimize resistance.
- Partner with Precision IT Business Relations Managers to ensure integration of applicable system roll-outs.
- Oversee Implementation and Business Operations team and ensure that: (a) implementation timeline of new functionality is in alignment with CTMS roadmap and operating model, and (b) there is optimal transition in each phase from implementation to operations.
- Work with stakeholders across Clinical Solutions to assure that the CTMS operations support the business requirements of all three main practice areas, including Oncology, Rare and Biopharma reporting requirements.
- Lead performance and volume metrics and escalating any existing or projected Program risks to meeting service level agreements.
- Represent CTMS business operations in organizational process improvement efforts; identify new opportunities to leverage CTMS data across Precision to improve transparency, efficiency, and compliance in clinical research-related operations.
- Lead CTMS Data Standards to ensure streamlined data entry and workflows supporting business requirements of Precision stakeholders. Oversee quality control functions of data requirements and escalate ongoing compliance issues to Executive Sponsors as appropriate.
- Manage end user system support functions according to service level agreements, including: facilitation of Precision user access process, triaging end user workflow/data entry issues, maintaining user SOPs and training materials.
- Establish and manage team(s) that perform high-volume operational tasks within Precision including: oncology and non-oncology clinical trials,
- Partner with Precision IT for the technical management and support of the CTMS. Work in partnership to plan for technical maintenance and upgrades and assure business impacts are assessed and communicated to appropriate stakeholders.
- Plan CTMS & eTMF Department growth according to Implementation Plan and evolving business needs of Precision's Clinical Solutions.
- Oversee and integrate the CTMS Implementation Plan into the operating model and budget, preparing for optimal operationalization of capabilities as it is delivered by the implementation team over a multi-year period.
- Manage the overall CTMS Program Budget, seeking approvals, providing timely updates and variance metrics to Executive Leadership.
- Recruit, train, motivate and manage CTMS & eTMF department staff. Develop and mentor staff based on goals, accountability, objectives, and priorities.
Minimum Required
- Master's Degree preferred.
- 15+ years of clinical research experience, includes relevant experience managing clinical research or enterprise
- Familiarity with a comprehensive range of clinical research areas and disease groups; including experience in both oncology and non-oncology (e. g., cardiology, nephrology) clinical research areas.
- Demonstrated strong governance management in a matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and to influence without authority when necessary.
- Solid foundation in data governance principles and experience managing large data sets.
- Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
- Working knowledge of clinical operations workflows; some knowledge of study management and reporting needs.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively in a highly-matrixed reporting environment to build strong partnerships.
- Working knowledge of and experience with Medidata Rave CTMS
- Working knowledge of and experience with TransPerfect Trial Interactive eTMF
- Experience working with vendors, including both software and consulting services.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Proficient in MS Excel
- Some experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms
- MS project or other GANTT charting and milestone development is a plus
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
Executive Director, Clinical Trial Management Systems CTMS eTMF(Remote)
Precision For Medicine
Denver Colorado
United States
Executive Management
(No Timezone Provided)
Position Summary
This position reports to the SVP Global Business Operations, and collaborates with the Chief Information Officer (CIO), as well as clinical executive leaders. The Executive Director, CTMS & eTMF will create strategic and transitional plans to support effective clinical trial management systems and electronic Trial Management Filing systems for Precision for Medicine. The Executive Director will be responsible for the development of a strategic direction for technology development and implementation to drive efficiencies. This individual will also highlight clinical informatics opportunities and requirements for global clinical trial operations and resolution of outstanding issues.
The Executive Director will have a solid understanding of the health care sector and familiarity with electronic health record systems including the standardization of data and processes. Advanced knowledge of contemporary information management, health and business processes, technologies and application and their application in solving complex health, business and operational problems.
Essential functions of the job include but are not limited to
- Develop and maintain a 3-5-year CTMS Strategic Roadmap outlining the timing and sequencing for delivering key business capabilities and enhancements to the CTMS to support tri-institutional business needs over the long term.
- Create and implement change management strategies and plans that maximize employee adoption and usage and minimize resistance.
- Partner with Precision IT Business Relations Managers to ensure integration of applicable system roll-outs.
- Oversee Implementation and Business Operations team and ensure that: (a) implementation timeline of new functionality is in alignment with CTMS roadmap and operating model, and (b) there is optimal transition in each phase from implementation to operations.
- Work with stakeholders across Clinical Solutions to assure that the CTMS operations support the business requirements of all three main practice areas, including Oncology, Rare and Biopharma reporting requirements.
- Lead performance and volume metrics and escalating any existing or projected Program risks to meeting service level agreements.
- Represent CTMS business operations in organizational process improvement efforts; identify new opportunities to leverage CTMS data across Precision to improve transparency, efficiency, and compliance in clinical research-related operations.
- Lead CTMS Data Standards to ensure streamlined data entry and workflows supporting business requirements of Precision stakeholders. Oversee quality control functions of data requirements and escalate ongoing compliance issues to Executive Sponsors as appropriate.
- Manage end user system support functions according to service level agreements, including: facilitation of Precision user access process, triaging end user workflow/data entry issues, maintaining user SOPs and training materials.
- Establish and manage team(s) that perform high-volume operational tasks within Precision including: oncology and non-oncology clinical trials,
- Partner with Precision IT for the technical management and support of the CTMS. Work in partnership to plan for technical maintenance and upgrades and assure business impacts are assessed and communicated to appropriate stakeholders.
- Plan CTMS & eTMF Department growth according to Implementation Plan and evolving business needs of Precision's Clinical Solutions.
- Oversee and integrate the CTMS Implementation Plan into the operating model and budget, preparing for optimal operationalization of capabilities as it is delivered by the implementation team over a multi-year period.
- Manage the overall CTMS Program Budget, seeking approvals, providing timely updates and variance metrics to Executive Leadership.
- Recruit, train, motivate and manage CTMS & eTMF department staff. Develop and mentor staff based on goals, accountability, objectives, and priorities.
Minimum Required
- Master's Degree preferred.
- 15+ years of clinical research experience, includes relevant experience managing clinical research or enterprise
- Familiarity with a comprehensive range of clinical research areas and disease groups; including experience in both oncology and non-oncology (e. g., cardiology, nephrology) clinical research areas.
- Demonstrated strong governance management in a matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and to influence without authority when necessary.
- Solid foundation in data governance principles and experience managing large data sets.
- Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
- Working knowledge of clinical operations workflows; some knowledge of study management and reporting needs.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively in a highly-matrixed reporting environment to build strong partnerships.
- Working knowledge of and experience with Medidata Rave CTMS
- Working knowledge of and experience with TransPerfect Trial Interactive eTMF
- Experience working with vendors, including both software and consulting services.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Proficient in MS Excel
- Some experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms
- MS project or other GANTT charting and milestone development is a plus
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .