As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Position leads Phase 1-3 Clinical Trials and oversees medical monitoring.
This is not a laboratory / research scientist role .
- In this role, the selected candidate will lead / support studies; be accountable for the clinical / scientific execution of the protocol;
- be the clinical point of contact for scientific issues / questions for internal and external stakeholders (e.g., IRB, sites);
and act as scientific lead on Clinical Trial Team (CTT)
Responsibilities include :
- Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication for investigators
- Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
- Sets up / supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF’s)
- Protocols / amendments collaborates with medical writing, participates in governance committee review; authors protocol clarification letters;
reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
May act as mentor to other Clinical Scientists
Education :
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
We are accepting applications on an ongoing basis, there is no deadline.
LI-Remote
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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