What are the responsibilities and job description for the Clinical Study Manager position at Labcorp?
Clinical Study Manager
Remote - United States
Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.
Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60 countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.
We are seeking a Clinical Study Manager who will support team with study budget planning and management and accountable for external spend related to study execution.
Responsibilities
- Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate
- Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
- Specific areas of sponsor oversight include, but are not limited to: oReview and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring oConduct Oversight Monitoring Visits, as applicable oReview and endorsement of relevant study plans, as applicable oStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutes oReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study oDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies oReview and ownership of trial operational data (e.g. CTMS) oReviewing and oversight of internal trial reports
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
- Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Site relationship management
Requirements *:
- Bachelor's Degree or international equivalent required; Life Sciences preferred.
- 5 years' experience in pharmaceutical industry and/or clinical research organization, including 3 years of clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
- Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
- Knowledge in global regulatory and compliance requirements for clinical research, including USCFR, EUCTD, and ICHGCP. Awareness of local country requirements is also required.
- Demonstrated successful experience in project/program management and matrix leadership E.g. timeline/budget management.
- Effective communication skills.
- Excellent teamwork, organizational, interpersonal, and problem-solving skills Fluent business English (oral and written).
- Vendor selection and oversight experience preferred
- Requires estimated 5-20 % travel, including overnight and international travel
Pay Range: $129,000 - $165,000/year
Benefits: All job offers will be?based on a candidate's skills and prior relevant experience, applicable?degrees/certifications,?as well as internal equity and market data.?Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here (https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf) .
#LI-Remote
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
Remote - United States
Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.
Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60 countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.
We are seeking a Clinical Study Manager who will support team with study budget planning and management and accountable for external spend related to study execution.
Responsibilities
- Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate
- Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
- Specific areas of sponsor oversight include, but are not limited to: oReview and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring oConduct Oversight Monitoring Visits, as applicable oReview and endorsement of relevant study plans, as applicable oStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutes oReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study oDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies oReview and ownership of trial operational data (e.g. CTMS) oReviewing and oversight of internal trial reports
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
- Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Site relationship management
Requirements *:
- Bachelor's Degree or international equivalent required; Life Sciences preferred.
- 5 years' experience in pharmaceutical industry and/or clinical research organization, including 3 years of clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
- Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
- Knowledge in global regulatory and compliance requirements for clinical research, including USCFR, EUCTD, and ICHGCP. Awareness of local country requirements is also required.
- Demonstrated successful experience in project/program management and matrix leadership E.g. timeline/budget management.
- Effective communication skills.
- Excellent teamwork, organizational, interpersonal, and problem-solving skills Fluent business English (oral and written).
- Vendor selection and oversight experience preferred
- Requires estimated 5-20 % travel, including overnight and international travel
Pay Range: $129,000 - $165,000/year
Benefits: All job offers will be?based on a candidate's skills and prior relevant experience, applicable?degrees/certifications,?as well as internal equity and market data.?Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here (https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf) .
#LI-Remote
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
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