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Senior Clinical Scientist / Medical Monitor – Oncology


This is a Full-time position in Atlanta, GA posted October 31, 2021.

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
– 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

Education/Qualifications :

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

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 in Oncology
Excellent Excel and PP skills required
Excellent written and oral communication skills

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