Centralized Study Lead

4 weeks ago

Vancouver, Canada Labcorp Full time

**Labcorp Drug Development**

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?**

**Centralized Start-Up Lead**

This role may be home based anywhere within the US or Canada.

**Essential Job Duties**:

- Primarily oversees and manages amendment phase of domestic and/or international clinical trials. Where required, may also take on start-up tasks under the direction of a Project Manager, Start-up.
- Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met.
- Lead the team through the amendment phase of a study.
- Responsibilities may also include activating sites in active start-up
- Serve as primary client contact with autonomy to interact directly with the client on a broad range of contract amendment issues and decisions
- Monitor and control project schedule. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met.
- Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure amendment deliverables are completed within agreed project timelines and in accordance with client’s expectations
- Proactively manage amendment progress, expectations and deliverables
- Understand client expectations for deliverables/milestones, and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
- Oversee preparation of amendment submission including but not limited to ICF updates/review/approval and other necessary documents
- Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met
- Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enroll status on time
- Review and provide input to core study documents, as applicable.
- Present at external and internal meetings including, but not limited to: project core team and client meetings.
- Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s).
- Support audits (internal and external) and inspections, as needed. Support resolution of any findings.

**FINANCE MANAGEMENT**
- Ensure that work is performed within budget. Interpret billing guidelines for the functional area/region and schedule training for start-up team accordingly
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems.
- Implement and follow pre-approved procedures for write off or budget overages.

**RESOURCE MANAGEMENT**
- Determine needs, request, and independently manage project start-up resources. Adapt/request resources as applicable to ensure project deliverables are met.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Identify and escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.
- Provide performance feedback of team members to respective line managers and project management team.

**Minimum Experience Required**:

- Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management.
- Preferably local project coordination and/or project management experience required
- Undertaken similar activities for > 6 months
- Direct Sponsor contact

**Preferred**
- Undertaken similar activities in > 1 country for more than 6 months
- Experience in oversight of start-up activities
- Experience outside of region

**Education Required**:

- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

**Pay range**: $ 70,000 - $100,000 USD

**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 discriminati

  • Judaic Studies Teacher

    2 weeks ago

    Vancouver, Canada King David High School Full time

    JUDAIC STUDIES TEACHER [Full time (1.0 FTE)]Starting Date: End of August 2024 Who we are: King David High School is a top-rated, independent school in central Vancouver with memberships in ISABC and CAIS. Our staff come from all walks of life and backgrounds - we value diversity. King David staff members enjoy working in a fun, caring, warm, supportive,...

  • Judaic Studies Teacher

    2 weeks ago

    Vancouver, Canada St. Clement's School Full time

    JUDAIC STUDIES TEACHER [Full time (1.0 FTE)] Starting Date: End of August 2024 Who we are: King David High School is a top-rated, independent school in central Vancouver with memberships in ISABC and CAIS. Our staff come from all walks of life and backgrounds – we value diversity. King David staff members enjoy working in a fun, caring, warm,...

  • Senior Study Manager

    11 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work. About The Role: As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    1 day ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work. About The Role: As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    10 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work. About The Role: As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    21 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work.About The Role:As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    16 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work. About The Role: As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    15 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work.About The Role:As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Senior Study Manager

    24 hours ago

    Vancouver, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work.About The Role:As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Judaic Studies/Hebrew Teachers

    2 weeks ago

    Vancouver, Canada King David High School Full time

    JUDAIC STUDIES / H EBREW TEACHERS (Part-time to Full-time, beginning September 2024) Who we are: King David High School is a top-rated, independent school in central Vancouver with memberships in ISABC and CAIS. Our staff come from all walks of life and backgrounds - we value diversity. King David staff members enjoy working in a fun, caring, warm,...

  • Dean, Faculty of Global and Community Studies

    1 month ago

    North Vancouver, Canada Capilano University Full time

    **Competition Number** - S181138P**Position Title** - Dean, Faculty of Global and Community Studies**Position Number** - A99993**Employee Group** - Administrator**Position Status** - Regular Full-Time**Start Date** - 08/01/2024**End Date (if applicable)** **Department** - Faculty of Global & Community Studies**Additional Notes** - This is a 5-year term,...

  • Judaic Studies/Hebrew Teachers

    1 week ago

    Vancouver, Canada British Columbia Public School Employers' Association | Make a Future - Careers in BC Education Full time

    JUDAIC STUDIES / H EBREW TEACHERS (Part-time to Full-time, beginning September 2024) Who we are: King David High School is a top-rated, independent school in central Vancouver with memberships in ISABC and CAIS. Our staff come from all walks of life and backgrounds – we value diversity. King David staff members enjoy working in a fun, caring, warm,...

  • Senior Study Manager

    4 hours ago

    Vancouver, BC, Canada Phase Consulting Full time

    Our client, a global leading engineering and consulting firm is seeking a Study Manager (Minerals and Metals). The role consists of 70% hands-on work, 30% leading work.About The Role:As the Study Manager,As a Study Manager, you oversee the early phases of project development in the mining resources sector, supporting our business development initiatives...

  • Dean, Faculty of Global and Community Studies

    4 weeks ago

    North Vancouver, Canada Capilano University Full time

    Posting Details Posting Summary Competition Number S181138P Position Title Dean, Faculty of Global and Community Studies Position Number A99993 Employee Group Administrator Position Status Regular Full-Time Start Date 08/01/2024 End Date (if applicable) Department Faculty of Global & Community Studies Additional Notes This is a 5-year term, renewable...

  • Dean, Global and Community Studies

    2 weeks ago

    North Vancouver, Canada Capilano University Full time

    Dean, Faculty of Global and Community StudiesPlease see Special Instructions for more details. Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer.  Posting Summary Competition Number Competition Number S181138P Position Title Position Title Dean, Faculty of...

  • Dean, Global and Community Studies

    2 weeks ago

    North Vancouver, Canada Capilano University Full time

    Dean, Faculty of Global and Community StudiesPlease see Special Instructions for more details. Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer.  Posting Summary Competition Number Competition Number S181138P Position Title Position Title Dean, Faculty of...

  • Dean, Global and Community Studies

    3 weeks ago

    North Vancouver, Canada Capilano University Full time

    Dean, Faculty of Global and Community StudiesPlease see Special Instructions for more details. Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer.  Posting Summary Competition Number Competition Number S181138P Position Title Position Title Dean, Faculty of...

  • Dean, Faculty of Global and Community Studies

    4 weeks ago

    North Vancouver, Canada Capilano University Full time

    Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer. Posting Details Posting Summary Competition Number S181138P Position Title Dean, Faculty of Global and Community Studies Position Number A99993 Employee Group Administrator Position Status Regular Full-Time Start...

  • Dean, Faculty of Global and Community Studies

    4 weeks ago

    North Vancouver, Canada Capilano University Full time

    Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer. Posting Details Posting Summary Competition Number S181138P Position Title Dean, Faculty of Global and Community Studies Position Number A99993 Employee Group Administrator Position Status Regular Full-Time Start...

  • Dean, Faculty of Global and Community Studies

    4 weeks ago

    North Vancouver, Canada Capilano University Full time

    Interested applicants should submit their cover letter, resume and proof of education. Capilano University is an equal opportunity employer. Posting Details Posting Summary Competition Number S181138P Position Title Dean, Faculty of Global and Community Studies Position Number A99993 Employee Group Administrator Position Status Regular Full-Time Start...