Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 35 hours ago

Regional Clinical Compliance Manager

Lifelancer3,681 open roles

Where
Remote
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowRegional Clinical Compliance ManagerLifelancer · Remote

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Lifelancer's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

11.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.9%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: first seen 35 hours ago

The posting

Job Title: Regional Clinical Compliance Manager

Job Location: Brazil Remote

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry

Location: Brazil Remote (close to Sao Paulo preferrable)

Please note this position can be filled at either the Manager or Senior Manager level depending upon experience.

General Description:

The Manager, Regional Clinical Compliance:

  • Is responsible for implementing Global Clinical Compliance (GCC) and Inspection Management strategy across BeOne Clinical activities at regional, country, study and/or site levels.
  • Independent from the Clinical Study Team (CST), provides compliance oversight as well as quality support to BeOne GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
  • Seeks opportunities to implement best practices, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
  • Supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
  • Tracks and trends non-compliance issues, quality events, and any other relevant observations identified during Site Compliance Visits (SCV), to help identify issues and risks across BeOne study programs and processes.
  • Supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
  • Adheres to ICH/GCP, local regulations, applicable BeOne SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.
  • Demonstrates significant clinical study experience and understanding of investigational site setup, trial management and conduct at a study and site level, and clinical operations processes.
  • Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
  • Supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned.

Essential Functions:

.

  • Provides GCP compliance guidance and support to BeOne CST and other GCO stakeholders for the assigned portfolio of studies in the applicable regulatory requirement(s) and SOPs.
  • Supports remote compliance review targeting business-critical clinical studies to detect potential non-compliance risk, issues and assess the inspection steady status of identified studies.
  • Performs periodic risk evaluations for assigned studies to identify investigator sites showing signals of non-compliance by reviewing and comparing existing study data and collaborating with relevant stakeholders, e.g. regional & country GCO, Study RCC counterparts, g/rCSMs, CRAs and relevant line managers.
  • Plans and conducts SCVs at identified investigator sites to observe and assess the quality of the monitoring and study conduct at sites, and proactively identify compliance issues at site, study, and/or monitoring level.
  • Evaluates the quality and integrity of site practices, escalating quality and/or GCP non-compliance issues to investigators, site staff and internal GCO team as appropriate.
  • Assesses classification and severity of on-site and remote compliance observations identified per appropriate SOPs and shares SCV outcome with relevant BeOne stakeholders.
  • Completes on-site and remote compliance visit reports within BeOne-specified timelines per SOP.
  • Follows up with action owners and key stakeholders, such as the CRA, CRA Line Manager, Country / Functional representative, and g/rCSM to support the timely resolution of reported on-site and remote compliance visit observations and ensure appropriate corrective and preventive action plans (CAPA) are implemented to address observations and mitigate related risks.
  • Ensures that action owners are clearly identified for each on-site and remote compliance visit observation and CAPA developed within timelines as specified in relevant BeOne SOPs.
  • Ensures that all relevant GCC & RCC systems and tools are used to schedule and document on-site and remote compliance visits.
  • Conducts peer review of site compliance visit reports.
  • Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
  • Supports trend analysis using on-site and remote compliance visit observations and supports compliance dashboard development and maintenance, supports ongoing risk assessment to ensure quality standards are being met and addresses concerns associated with study delivery at sites.
  • Provides constructive feedback on CRAs and other team members performance to their line managers to support performance review as applicable.
  • Provides feedback on investigator site performance for future study feasibility purposes.

Manager Minimum Requirements – Education and Experience:

  • Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline* with minimum of 5 years of progressive experience in clinical operations roles.
  • Minimum 2 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
  • Minimum 4 years’ experience in a lead monitoring or trial oversight role.
  • Experience in oncology global trials is preferred.

*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.

Senior Manager Minimum Requirements – Education and Experience:

  • Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline* with minimum of 7 years of progressive experience in clinical operations roles.
  • Minimum 2 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
  • Minimum 4 years’ experience in a lead monitoring or trial oversight role.
  • Experience in oncology global trials is preferred.

*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.

Other Experience:

  • Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
  • Analytical and problem-solving skills
  • Organizational, project management and leadership skills
  • Excellent English written and verbal communication and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi-task
  • Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment

Supervisory Responsibilities: May coach or mentor junior team members.

Travel: up to 50-75% travel

Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

#LinkedIn

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Lifelancer's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Lifelancer's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Lifelancer's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.