Clinical Trial Operations Manager - Sao Paulo, Brasil - BeiGene

BeiGene

Empresa verificada

Sao Paulo, Brasil

há 3 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement:
Fluent English and Portuguese. Spanish is a plus.

Preferred Experience:
Pharmaceutical/Biotech Industry, Hematology, Oncology

Company Overview:
BeiGene, Ltd

(NASDAQ:

BGNE;

HKEX:
is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics.

With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer.

BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients

General Description:

The CTOM is a partner to their assigned Clinical Study Teams (CST) focusing on oversight of site monitoring activities to ensure data quality and patient safety in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.

The CTOM identifies risk strategies per appropriate SOPs for their assigned portfolio and conducts Site oversight visits to observe and assess quality of the monitoring.

Where issues and risks are identified, the CTOM collaborates with the CRA(s) and CRA Line Management to ensure appropriate corrective and preventive actions are in place.

The CTOM also supports site and country intelligence in assigned regions/countries, developing strong relationships with sites, networks and advocacy groups.

Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region

Essential Functions:

Responsible for the assigned portfolio of studies, and performs oversight activities and engagement visits per applicable SOPs
Is a primary liaison with regard to Risk identification and mitigation throughout study lifecycle
Responsible for site relationship and quality of site activities as they relate to BeiGene protocols.
Responsible for oversight of monitoring quality, protocol execution, and patient safety
Responsible for developing outreach plans for continued engagement with sites
May mentor or support CRAs on study specific challenges
Acts as the escalation point person for study teams with issues and concerns related to monitoring quality and/or site performance
Conducts and reports Quality Oversight Visits (QOV) aka Site Oversight Visits (SOVs) to proactively identify issues on a study, site, and CRA level, as well as ensuring resolution of issues identified
Completes QOV/SOV reports within BeiGenespecified timelines
Conducts Investigator Engagement Contact report (IEC), within BeiGenespecified timelines, to proactively identify new potential investigators for BeiGene and inform current investigators of potential new work.
Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards
Assists with investigator/site identification
In partnership with CST, provides protocol and related study training to assigned sites
Manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites.
Collaborates with clinical operations team and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
Collaborates on or reviews studyspecific Project Management Plans
Attends disease indication project specific training and general CTOM training, as required
Provide support for site audits/inspections, as needed, and followthrough with audit/inspection findings to resolution
Evaluates the quality and integrity of site practices, escalating quality and/or GCP issues with investigators and internal team as appropriate
May conduct comonitoring visits, as needed

Minimum Requirements - Education and Experience:

BS/BA in a relevant scientific discipline and minimum of 5 years of relevant Clinical Operations experience; 1-2 of those being trial management experience, and minimum of 3-5 years of monitoring experience.

Experience in oncology global trials preferred

Other Qualifications:

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
Minimum of 5 years working in Clinical Operations
Combination of 12 years of trial management or oversight within pharmaceutical or CRO Industry and 35 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multitask

Supervisory Responsibilities: