Senior Manager, Business Operations - Clinical Development
Position
Summary:
The Senior Manager, Business Operations, under the direction of the Director, Business Operations and Analytics, provides leadership and oversight for assigned projects to support process improvement efforts in alignment with business objectives, that may include business process optimization and documentation, process metrics development, business analytics support, business rules for relevant systems, and project communication, change and risk management activities. Essential duties and responsibilities include, but are not limited to, the following:
Business owner for assigned business applications and/or analytics solutions in partnership with IT (e.g. eTMF, CTMS) Team lead for projects, including project management, communication, and change and risk management Development and oversight of business process metrics, including business requirements for technology solutions to support the oversight process, risk identification and mitigation Develop and implement short and long-term strategies and road maps in partnership with the Head of Business Operations and Analytics, IT, and other key stakeholders for assigned projects Manage complex internal and external relationships across the business operations portfolio Lead and contribute to cross-departmental process improvement projects Subject matter expert in at least one domain area, including but not limited to eTMF, CTMS, Veeva Clinical platform, and Business Intelligence tools such as Tableau Develop and implement business requirements for process, systems, and analytics in partnership with relevant stakeholders Training and onboard new team members and/or study teams on business application processes and best practices Oversight of business operations vendors, including leading team meetings, assessing vendor performance, risk management and issue escalation Ensure routine distribution of business operations status updates to management teams and/or vendor partners with follow-up and resolution of identified actions Support IT in business application migrations, transfers and file-location mapping documentation to/from CROs and partners, as applicable Participate as a subject matter expert during audits and inspections and assist QA is audit preparedness activities People management responsibilities, including performance management, resource management, and development planning
Qualifications:
BA/BS degree or equivalent experience 6-9
years of experience in industry 2-3 years of experience directly managing people, including performance management, resource management, and development planning Depth of experience in common Clinical Development systems and analytics tools, including eTMF, CTMS, Tableau, Excel, Veeva platform, Visio Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members This position requires detailed management of timelines, the ability to multitask, and adaptation to rapid change in the conduct of multiple, sometimes complex, clinical trials Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Development organization Demonstrated leadership ability Experience leading and/or contributing to the selection of systems and vendors To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Senior Manager, Business Operations, under the direction of the Director, Business Operations and Analytics, provides leadership and oversight for assigned projects to support process improvement efforts in alignment with business objectives, that may include business process optimization and documentation, process metrics development, business analytics support, business rules for relevant systems, and project communication, change and risk management activities. Essential duties and responsibilities include, but are not limited to, the following:
Business owner for assigned business applications and/or analytics solutions in partnership with IT (e.g. eTMF, CTMS) Team lead for projects, including project management, communication, and change and risk management Development and oversight of business process metrics, including business requirements for technology solutions to support the oversight process, risk identification and mitigation Develop and implement short and long-term strategies and road maps in partnership with the Head of Business Operations and Analytics, IT, and other key stakeholders for assigned projects Manage complex internal and external relationships across the business operations portfolio Lead and contribute to cross-departmental process improvement projects Subject matter expert in at least one domain area, including but not limited to eTMF, CTMS, Veeva Clinical platform, and Business Intelligence tools such as Tableau Develop and implement business requirements for process, systems, and analytics in partnership with relevant stakeholders Training and onboard new team members and/or study teams on business application processes and best practices Oversight of business operations vendors, including leading team meetings, assessing vendor performance, risk management and issue escalation Ensure routine distribution of business operations status updates to management teams and/or vendor partners with follow-up and resolution of identified actions Support IT in business application migrations, transfers and file-location mapping documentation to/from CROs and partners, as applicable Participate as a subject matter expert during audits and inspections and assist QA is audit preparedness activities People management responsibilities, including performance management, resource management, and development planning
Qualifications:
BA/BS degree or equivalent experience 6-9
years of experience in industry 2-3 years of experience directly managing people, including performance management, resource management, and development planning Depth of experience in common Clinical Development systems and analytics tools, including eTMF, CTMS, Tableau, Excel, Veeva platform, Visio Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members This position requires detailed management of timelines, the ability to multitask, and adaptation to rapid change in the conduct of multiple, sometimes complex, clinical trials Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Development organization Demonstrated leadership ability Experience leading and/or contributing to the selection of systems and vendors To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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