Job Overview: Senior Clinical Scientist - Oncology, Clinical Trial Mgmt and Medical Monitoring experience is required Remote in the USA or Canada 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 ?
Covance by Labcorp gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks ? W orking at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
Dedicated to an FSP project , you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance , we have an FSP opportunity to match your area of expertise.
You will enjoy the best of both worlds-all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.
Our model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.
Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are locat ed on the globe, we have an FSP opportunity for you.
In this role, the selected candidate may lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
As lead, will be responsible for the following:
- 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, bio specimens 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 review 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
- Supports SM/MW activities as needed to achieve CTT deliverables.
- Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
- May act as mentor to other CSs
- 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
- COVID-19 vaccination required
- Minimum 2 years 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
- Excellent Excel and PP skills required
- Excellent written and oral communication skills