Clinical Research Manager - Santiago de Chile - Fortrea

Fortrea

Empresa verificada

Santiago de Chile

hace 1 semana

Publicado por:

Valentina Hurtado

beBee Recruiter

Descripción

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.

Tasks and Responsibilities:

Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team
Responsible for project management of the assigned studies: actively plans, drive and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out
Review Monitoring Visits Reports and raise performance issues and training needs to CRA manager and/or functional vendor and internal management as needed
Perform Quality control visits as required
Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and supports CRAs as protocol guide and coordinate activities across the different local country roles ensuring a strong collaboration
Responsible for crafting and executing a local risk management plan for assigned studies
Ensure compliance with CTMS, eTMF and other key systems
Raises as needed different challenges and issues
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners
Country point of contact for programmatically outsourced trials
Serve local business needs as applicable in his/her country (If delegated can sign contracts and run budgets)
Collaborate internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies
As a customerfacing role, this position will build business relationships and represent the company with investigators
Share protocolspecific information and standard methodologies across countries\clusters

Education, Skills and Other Requirements:

University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Previous experience in clinical research in pharmaceutical or CRO industries
Previous experience in managing trials
Deep understanding of local regulatory environment
Strong understanding of clinical trial planning, management and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time
Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery
Strong organizational skills and time management skills
Excellent interpersonal skills
Proficiency in written and spoken English

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

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