Covance Senior Clinical Scientist - Clinical Trial Mgmt and Medical Monitoring exp required in Columbia, South Carolina
Senior Clinical Scientist
Clinical Trial Mgmt and Medical Monitoring experience is required
Remote in the USA or Canada
Why settle for one thing when you can have everything?
Covance gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
As a Covance employee 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, Covance has an FSP opportunity to match your area of expertise.
You will enjoy the best of both worlds—all the benefits that come along with Covance’s 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.
Covance’s FSP 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.
Covance’s reach is global – extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.
In this role, the selected candiate 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
#LI - Remote
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 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 beneficial
Excellent Excel and PP skills required
Excellent written and oral communication skills
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.