Massachusetts Veterans Jobs

Senior Clinical Scientist

Remote - USA

Infectious Disease or Vaccines

Position leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role.

Why settle for one thing when you can have everything?  

Labcorp Drug Development gives you the best opportunity for career growth. 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 CROs. So no matter where you are located on the globe, we have an opportunity for you!

In this role, the selected candidate responsible for the clinical/scientific conduct of clinical studies e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management; may support a single study or multiple studies; may lead a study with limited scope (e.g., Survival Follow-up); and may interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives

Additional Responsibilities include:

• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)

• Responsible for trial design and endpoint development in collaboration with CD

• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports

• Sets up/supports SAC, DMC, adjudication committees

• Protocols/amendments – collaborates with medical writer, participates in governance committee review

• Authors protocol clarification letters

• Contributor to study specific documents (e.g., SMP)

• Reviews/updates informed consent

• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)

• Monitors data issues requiring clinical input

• Monitors central lab reports and other external data for safety and critical values

• Prepares scientific slides, attends and presents protocol information at Investigator Meeting

• Scientific lead on Clinical Trial Team (CTT)

• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system

• Coordinates planning of lab, biospecimens and imaging specifications

• Co-authors newsletters with SM

• Participates in Database lock activities

• Collaboratively plans CSRs, CTDs/WMAs with medical writing

• Supports publications/presentations as needed

• Reconciles and reviews all protocol deviation classifications in SPECTRUM

• Assesses and prepares protocol deviation list for CSR

• Collaborates with medical writing to develop trial results communication for investigators

• Provides scientific assessment for Operational Reviews

• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)

Requirements:

• Degree in Life Sciences or significant experience in clinical development (>14 years)

• BS/BA with 7+ yrs clinical research experience

• MS/PhD with 5+ years clinical research experience

• Minimum 2 years of pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.

• Proven ability to effectively manage multiple complex studies

• Medical monitoring experience required

• TA-specific experience in Oncology required

• Excellent Excel and PP skills required

• Excellent written and oral communication skills

• COVID-19 vaccination required

Great Benefits at Labcorp:

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

   

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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