Senior Director for Clinical Trials Operations
SENIOR DIRECTOR FOR CLINICAL TRIALS OPERATIONS The Senior Director for Clinical Trials Operations will plan and execute a strategy to establish Southern Research's (SR) clinical trials operations (CTO).
As founding director of this new business line, the Senior Director for the CTO service line will develop and maintain a robust strategic alliance with the University of Alabama Birmingham's (UAB) O'Neal Comprehensive Cancer Center (O'Neal) and its affiliates.
Principally, the Senior Director will be responsible for preparing SR's clinical trial service lines to serve the O'Neal while laying the groundwork for future expansion to meet the needs of key clients and align with market opportunities.
This will involve building a team, establishing protocols, developing milestones, preparing budgets, and establishing the strategic direction for clinical trials services offered by SR initially in alignment with the clinical trials operations at the O'Neal.
The Senior Director will be charged with building a team at Southern Research to build and augment SR's Data and Quality Management systems and personnel to provide broader clinical trials services going forward with the expectation of expanding this SR service line beyond the O'Neal.
This position will report to the Vice President for Research Services at Southern Research.
The specific expectations will include:
Develop and implement a multi-year strategy for Southern Research's Clinical Trial Operations, including a budget, strategic milestones Establish an SR Clinical Trial Integration Management Team to achieve best practices for the clinical trials services in SR's clients to include:
Best staffing organization and practices for clinical trials operations of different sizes Clinical trials budgeting and invoicing, coordination, data management, regulatory oversite, quality assurance and education and training Bets practices for oversight of clinical trials at affiliate sites Develop well-structured mechanisms to support development, conduct and reporting of investigator-initiated trials and multi-site trials Oversee SR service line which provides support for key clients including participating in audit debriefings, review all audit/monitoring visit reports, and collaborate with the key personnel to develop, implement, and monitor corrective action plans; Work closely with key clients and stakeholders to ensure that clinical research initiatives are efficiently and effectively integrated with the delivery of clinical services both in the inpatient and outpatient setting.
Create novel strategies for efficient and effective outsourcing of specific clinical trials activities to SR and other organizations.
In conjunction with SR's contracts group, establish a framework agreement allowing for the establishment of strategic partnerships detailing contractual relationship for the services provided.
Provide executive and administrative services to UAB to assist UAB in rebuilding the UAB O'Neal Clinical Trials Operations to increase efficiencies, including providing consulting services to address and build hiring, training and quality assurance processes.
Minimum Qualifications/Requirements B.
S.
in Biomedical related discipline (Biochemistry, Molecular Biology, etc.
) Minimum of 15 years of related experience plus at least 7 years of management experience.
Significant experience in administration of cancer related clinical trials preferred.
Recommended Skills Accounts Receivable Administration Auditing Biochemistry Biomedical Engineering Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
As founding director of this new business line, the Senior Director for the CTO service line will develop and maintain a robust strategic alliance with the University of Alabama Birmingham's (UAB) O'Neal Comprehensive Cancer Center (O'Neal) and its affiliates.
Principally, the Senior Director will be responsible for preparing SR's clinical trial service lines to serve the O'Neal while laying the groundwork for future expansion to meet the needs of key clients and align with market opportunities.
This will involve building a team, establishing protocols, developing milestones, preparing budgets, and establishing the strategic direction for clinical trials services offered by SR initially in alignment with the clinical trials operations at the O'Neal.
The Senior Director will be charged with building a team at Southern Research to build and augment SR's Data and Quality Management systems and personnel to provide broader clinical trials services going forward with the expectation of expanding this SR service line beyond the O'Neal.
This position will report to the Vice President for Research Services at Southern Research.
The specific expectations will include:
Develop and implement a multi-year strategy for Southern Research's Clinical Trial Operations, including a budget, strategic milestones Establish an SR Clinical Trial Integration Management Team to achieve best practices for the clinical trials services in SR's clients to include:
Best staffing organization and practices for clinical trials operations of different sizes Clinical trials budgeting and invoicing, coordination, data management, regulatory oversite, quality assurance and education and training Bets practices for oversight of clinical trials at affiliate sites Develop well-structured mechanisms to support development, conduct and reporting of investigator-initiated trials and multi-site trials Oversee SR service line which provides support for key clients including participating in audit debriefings, review all audit/monitoring visit reports, and collaborate with the key personnel to develop, implement, and monitor corrective action plans; Work closely with key clients and stakeholders to ensure that clinical research initiatives are efficiently and effectively integrated with the delivery of clinical services both in the inpatient and outpatient setting.
Create novel strategies for efficient and effective outsourcing of specific clinical trials activities to SR and other organizations.
In conjunction with SR's contracts group, establish a framework agreement allowing for the establishment of strategic partnerships detailing contractual relationship for the services provided.
Provide executive and administrative services to UAB to assist UAB in rebuilding the UAB O'Neal Clinical Trials Operations to increase efficiencies, including providing consulting services to address and build hiring, training and quality assurance processes.
Minimum Qualifications/Requirements B.
S.
in Biomedical related discipline (Biochemistry, Molecular Biology, etc.
) Minimum of 15 years of related experience plus at least 7 years of management experience.
Significant experience in administration of cancer related clinical trials preferred.
Recommended Skills Accounts Receivable Administration Auditing Biochemistry Biomedical Engineering Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
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