What are the responsibilities and job description for the Senior Study Manager position at Labcorp?
Senior Study Manager
Remote - United States
Oncology Required
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
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.
We are seeking a Senior Study Manager to be responsible for operational deliverables including managing the Clinical Trial Team (CTT), supporting clinical supplies planning, site readiness, country allocation, and achievement of recruitment targets.
Additional responsibilities may include:
- Operational POC for trial execution and deliverables
- Manages and Leads Global CTT (Clinical Trial Team), supports clinical supply planning, and manages external vendors
- Initiates planning for investigator meetings and protocol training
- Plans and assesses protocol ancillary supplies
- Completes trial set up and maintains CTMS
- Initiates recruitment/retention and enrollment planning for protocols (globally)
- Responsible for creating and maintaining project schedule and collaborating with Program Lead
- Set up and maintain eTMF
- Ensures alignment of budget with protocol needs and responsible for executing protocol within the budget
- Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group
- Manages Emergency Unblinding (EUB) Call Center activities
- Oversees all HQ close-out tasks
- Interface with External Data Coordination and Data Management
- Responsible for creating and maintaining ADI logs
- Responsible for risk assessment, mitigation, planning and all protocol plans
- Responsible for end of study reconciliation globally (clinical & ancillary supplies)
- Responsible for quality control and inspection readiness at all times
Requirements:
- BS/BA/MS/PhD with 7 years of clinical research experience
- Minimum of 2 years' of pharmaceutical experience as a lead SM/PM required
- Global trial experience required
- Proven ability to meet aggressive timelines
- Excellent MS Excel and PowerPoint skills
- Excellent oral (including presentation) and written communication, database management, and project management skills
Preferred Experienced:
- MS Project experience
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
Oncology Required
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
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.
We are seeking a Senior Study Manager to be responsible for operational deliverables including managing the Clinical Trial Team (CTT), supporting clinical supplies planning, site readiness, country allocation, and achievement of recruitment targets.
Additional responsibilities may include:
- Operational POC for trial execution and deliverables
- Manages and Leads Global CTT (Clinical Trial Team), supports clinical supply planning, and manages external vendors
- Initiates planning for investigator meetings and protocol training
- Plans and assesses protocol ancillary supplies
- Completes trial set up and maintains CTMS
- Initiates recruitment/retention and enrollment planning for protocols (globally)
- Responsible for creating and maintaining project schedule and collaborating with Program Lead
- Set up and maintain eTMF
- Ensures alignment of budget with protocol needs and responsible for executing protocol within the budget
- Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group
- Manages Emergency Unblinding (EUB) Call Center activities
- Oversees all HQ close-out tasks
- Interface with External Data Coordination and Data Management
- Responsible for creating and maintaining ADI logs
- Responsible for risk assessment, mitigation, planning and all protocol plans
- Responsible for end of study reconciliation globally (clinical & ancillary supplies)
- Responsible for quality control and inspection readiness at all times
Requirements:
- BS/BA/MS/PhD with 7 years of clinical research experience
- Minimum of 2 years' of pharmaceutical experience as a lead SM/PM required
- Global trial experience required
- Proven ability to meet aggressive timelines
- Excellent MS Excel and PowerPoint skills
- Excellent oral (including presentation) and written communication, database management, and project management skills
Preferred Experienced:
- MS Project experience
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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