Manager, EDC Administration

Posted Yesterday
Be an Early Applicant
Hiring Remotely in Cambridge, Cambridgeshire, England, GBR
In-Office or Remote
126K-166K Annually
Senior level
Biotech
The Role
Lead US EDC administration for BeiGene clinical studies: configure EDC (users, sites, lab ranges), support integrations (CTMS, IRT, MDM), perform QC and testing of data loads/reports, create SOPs/WIs/templates, maintain documentation, supervise audits and EDC admins, and collaborate with cross-functional pharma teams.
Summary Generated by Built In

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.

BeOne Medicines USA, Inc. seeks Manager, EDC Administration in Cambridge, MA:

Job Duties: Act as Data Management administrator lead in US for BeiGene EDC clinical studies. Assist with supporting cross functional systems such as CTMS, IRT etc. as needed and help setup necessary integrations. Add users, sites and upload local lab ranges in various EDC Systems. Assist with subject administration as well as site numbering process. Support integration between EDC and MDM. Perform quality control of Admin tasks. Generate and maintain all required documentation in support of DM Admin activities. Assist with Creation of SOPs, WIs and Templates for EDC administration. Help test external data loads, custom reports, integrations, EDC builds; and Supervise audit activities and Manage work of EDC Admins. Full-time telecommuting is an option.

Minimum Requirements: Master’s degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or closely related field, and 5 years of experience in the job offered or in any occupation in related field; or a Bachelor’s degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or closely related field, and 7 years of experience in the job offered or in any occupation in related field.

Special Skill Requirements: (1) Experience with Clinical Systems (Medidata Rave, Oracle Inform, Oracle CTMS, Medidata CTMS); (2) Experience Administering Clinical Data Warehouse Solutions; (3) Experience Creating and Maintaining SOPs and Work Instructions; (4) Experience using ticketing systems (Jira and Service Now); (5) Experience working with Pharma/Biotech cross-functional teams (Clinical Operations, Safety, Biometrics); (6) Experience with the systems and regulatory aspects of clinical trials; (7) Experience with industry standards (CDISC, 21 CFR Part 11, ICH GCP). Any suitable combination of education, training and/or experience is acceptable. Full-time telecommuting is an option.

Disregard the below range, the selected candidate will earn a wage of $136,406 - $165,000 per annum.

Submit resume with references to: Req.#: L24-150312 at: ATTN: Amy Nobriga, [email protected].

#LI-DNI

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

Salary Range: $125,500.00 - $165,500.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].

Skills Required

  • Master's degree in Computer Science, Engineering, or related field and 5 years relevant experience OR Bachelor's degree and 7 years relevant experience
  • Experience with Medidata Rave
  • Experience with Oracle Inform
  • Experience with Oracle CTMS
  • Experience with Medidata CTMS
  • Experience administering Clinical Data Warehouse solutions
  • Experience creating and maintaining SOPs, Work Instructions, and templates
  • Experience using ticketing systems (Jira and ServiceNow)
  • Experience working with Pharma/Biotech cross-functional teams (Clinical Operations, Safety, Biometrics)
  • Experience with systems and regulatory aspects of clinical trials
  • Familiarity with industry standards (CDISC, 21 CFR Part 11, ICH GCP)
  • Experience supporting integrations between EDC and systems (CTMS, IRT, MDM) and testing external data loads, custom reports, and EDC builds
  • Ability to add users/sites, upload local lab ranges, support subject administration and site numbering processes
  • Perform quality control of administrative tasks and generate/maintain required documentation for DM Admin activities
  • Supervise audit activities and manage the work of EDC Administrators

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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