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

Open nowPosted 2 days ago

Clinical Study Manager

BeOne Medicines271 open roles

Where
São Paulo
Get the CV for this job

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

Your applicationOpen nowClinical Study ManagerBeOne Medicines · São Paulo

  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 BeOne Medicines'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.

10.5% of postings close within 7 days. Measured by our own scanner across the market. BeOne Medicines postings stay open a median of 37 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 2 days ago

BeOne Medicines median: 37 days open

The posting

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: Sao Paulo Hybrid

General Description:

  • Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities
  • Works to ensure adherence to a standardized approach to clinical trial management
  • Manage clinical trial projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters
  • Exhibits a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives
  • People management which includes performance oversight and development, quarterly check-ins and year-end performance reviews
  • Mentoring of team members

Essential Function:

Quality

  • Ensures that TMF for assigned clinical trial(s) is created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are being adhered to
  • Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance
  • Manages Central Lab and ancillary vendors selection, set-up, conduct, and close-out for BeiGene studies.
  • Oversees and/or delegates the management and oversight of study vendors (CRO) to ensure that BeiGene’s clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial deliverables and performance goals are met.
  • Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs

Timelines

  • Escalation point person to Clinical Program Lead and Program Management Lead when necessary.
  • Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed for Health Authority submissions by working with Regulatory Affairs to establish timeframes for submissions and ensure clarity of documentation required
  • Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
  • Supports timely and efficient database by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts

Budget

  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
  • Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts
  • Participates in clinical trial scenario planning (estimates time and cost)

Planning/Leading

  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close-out to ensure both internal and external deliverables are on time and on budget
  • Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity
  • Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to clinical study issues that may arise
  • Delegates and oversees the management of certain aspects of project management to junior staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.

Minimum Requirements – Education and Experience:

  • Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 5 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment.

Other Experience:

  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
  • Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
  • Proficient written and verbal communication skills.
  • Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Management experience of CROs, Vendors and Consultants preferred.
  • Therapeutic or medical knowledge preferred
  • Regulatory authority inspection experience a plus
  • Strong written and verbal communication skills.

Supervisory Responsibilities:

  • Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans

Travel:

  • Up to 10 - 15%

Computer Skills:

  • MS Office, Project Planning Applications

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.

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 BeOne Medicines'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 BeOne Medicines'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

    BeOne Medicines'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.