(Senior) CRA

Posted Yesterday
Be an Early Applicant
Hiring Remotely in Office, Machaze, Manica, MOZ
Remote
Senior level
Biotech
The Role
Monitor oncology and hematology clinical trials including site initiation, routine monitoring, closeout, and quality oversight. Ensure GCP/ICH compliance, manage site communications, recruitment tracking, CRF completion, query resolution, and support site submissions, contracts, and training. Complete monitoring and QOV reports timely and assist with trial management and investigator identification as needed.
Summary Generated by Built In

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description:

The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country.

The CRA is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
 

How you will add value:

  • Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require

  • Conducts co-monitoring visits, if required

  • Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)

  • Attends onboarding-, disease indication and project specific training and general CRA training as required

  • Documents monitoring activities appropriately following ICH-GCP and BeiGene standards

  • Conducts Quality Oversight Visits (QOV), as requested

  • Completes monitoring visit/ QOV reports timely

  • Assists with investigator/site identification

  • Assists site to prepare Ethics Committee submissions

  • Facilitates clinical trial site contract and budget negotiation

  • Manages site queries and communications

  • Assists in managing clinical trials, if required

  • Establishes regular lines of communication with sites and COMs

  • Provides protocol and related study training to assigned sites

  • Evaluates the quality and integrity of site practices – escalating quality issues as appropriate

  • Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

  • Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed

  • Performs additional task as assigned

Qualification Required:

What we expect from the successful candidate:
  • Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical

  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

  • +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry

  • Excellent communication and interpersonal skills

  • Excellent organizational skills and ability to prioritize and multi-task

  • Fluent in English (writing and speaking)

What We Offer To Our Valued Employees

  • Market competitive compensation package including performance-based annual bonus scheme

  • Company shares (generous welcome grant!)

  • In-house and external learning and development opportunities

  • Fantastic benefits program and keep improving!

  • Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

  • Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

Skills Required

  • Bachelor's degree or above in life sciences, pharmacy, nursing or medical
  • Thorough knowledge of ICH and associated regulatory guidelines and clinical trial processes (GCP)
  • +1 year monitoring experience in the pharmaceutical or CRO industry (Over 4 years for SCRA)
  • Excellent communication and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi-task
  • Fluent in English (writing and speaking)

BeiGene Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BeiGene and has not been reviewed or approved by BeiGene.

  • Equity Value & Accessibility Equity grants and stock programs are widely available across roles, including RSU grants at hire and opportunities to participate in company equity plans. Total compensation commonly includes equity alongside base pay and incentives.
  • Healthcare Strength Health coverage is described as comprehensive and high quality, with multiple mentions of “top notch” medical benefits. This strength is consistently highlighted as a key component of the package.
  • Retirement Support Retirement offerings include a 401(k) with a competitive employer match. These features contribute to a strong overall compensation bundle.

BeiGene Insights

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The Company
HQ: Cambridge, MA
2,862 Employees
Year Founded: 2010

What We Do

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal. See our community guidelines: bit.ly/39o3O6j

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