Clinical Trial Operations Manager

7 meses atrás

Sao Paulo, Brasil BeiGene Tempo inteiro

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: 06160) 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 BeiGene-specified timelines
- Conducts Investigator Engagement Contact report (IEC), within BeiGene-specified 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 study-specific Project Management Plans
- Attends disease indication project specific training and general CTOM training, as required
- Provide support for site audits/inspections, as needed, and follow-through 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 co-monitoring 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 1-2 years of trial management or oversight within pharmaceutical or CRO Industry and 3-5 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task

Supervisory Responsibilities:

- Provides oversight management for assigned portfolio of studies
- Provides mentoring/support to CRAs for study rela

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