Key Responsibilities:
- Serve as the primary liaison for Field CRAs, supporting site management and monitoring activities remotely.
- Conduct remote site visits for routine monitoring, enrollment, and quality assurance.
- Assist with site identification, qualification, and activation, including budget and contract coordination.
- Maintain and manage Trial Master File (TMF) documentation in compliance with GCP and internal standards.
- Oversee third-party vendors (e.g., central labs) to ensure timely and quality deliverables.
- Collaborate with clinical and data management teams to ensure data integrity and compliance.
- Track and support study supply logistics (e.g., drug supply, lab samples).
- Provide support during audits and inspections.
- Perform other duties as assigned by the Manager.
Qualifications:
- Bachelors degree in life sciences, pharmacy, or a related field; or equivalent professional experience.
- Bilingual in English and Spanish (Portuguese is a plus).
- Minimum 2+ years of experience in clinical operations within a pharmaceutical, biotech, or CRO setting.
- At least 3 years of direct monitoring experience.
- Experience with various EDC platforms.
- Experience in oncology clinical trials across all study phases preferred.
- In-depth knowledge of GCP, ICH, and FDA regulations.
- Excellent organizational, communication, and collaboration skills.
- Must be eligible to obtain a Business Work Visa for Peru.
Actalent est un chef de file mondial des services dingenierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires a faire progresser leurs initiatives en matiere dingenierie et de science en leur donnant acces a des experts specialises qui favorisent la mise a lechelle, linnovation et la mise en marche rapide. Avec un reseau de pres de 30000consultants et plus de 4500clients aux Etats-Unis, au Canada, en Asie et en Europe, Actalent est au service dun grand nombre dentreprises du classement Fortune 500.
Actalent est un employeur souscrivant au principe de legalite des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de lage, de la couleur, de la religion, des origines nationales, du statut dancien combattant, dun handicap, de lorientation sexuelle, de lidentite sexuelle, des renseignements genetiques ou de toute autre caracteristique protegee par la loi.
Si vous souhaitez faire une demande daccommodement raisonnable, tel que la modification ou lajustement du processus de demande demploi ou dentrevue a cause dun handicap, veuillez envoyer un courriel a ... pour connaitre dautres options daccommodement.
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ... for other accommodation options.