Senior CRA Functional Manager

🔥 17 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Develop resourcing strategies and provide personnel oversight within the Site Management organization • Develop metrics and KPIs for CRA staff and monitor continuous improvement using technology and analytic platforms • Lead CRA Managers and their staff, ensuring accountability for study assignments, training, and metrics review • Provide performance management, coaching, and mentoring for assigned management staff • Ensure monitoring expectations comply with monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based effectiveness standards • Conduct assessments, co-monitoring visits, Investigator meetings, or Booster visits as needed to evaluate CRA staff • Drive improvements to optimize effectiveness and efficiency within Site Management and the greater Americas region • Oversee monitoring quality and related metrics, including trip-report turnaround, trip-report quality, action-item management, query management, data currency, and TMF management • Manage relationships with CRO FSP line managers and respond to feedback regarding direct reports, studies, and programs • Act as escalation point for CTOMs and study teams regarding CRA-related issues and concerns • Ensure adequate monitoring allocations and relevant training for direct reports’ projects • Support BeiGene RBx strategy and engagement of direct reports • Document monitoring oversight activities according to ICH-GCP and BeOne standards • Assist with investigator and site identification • Manage site trends through dashboard review and ongoing risk assessment • Collaborate with clinical study teams and sites to deliver study milestones, including startup, recruitment, database analyses, and closeout • Establish communication with stakeholders to manage clinical delivery and report or escalate issues • Review monitoring reports for quality oversight • Support site audits and inspections and follow through on findings to resolution

🎯 Requirements

• BS/BA in a relevant scientific discipline • Minimum of 8-9 years of relevant Clinical Operations experience • 4-5 years combining personnel and trial management experience • Minimum of 4-5 years of monitoring experience • Experience in oncology global trials preferred • Knowledge of monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based monitoring • Ability to develop metrics and KPIs • Ability to conduct performance management, coaching, and mentoring • Ability to manage CRO FSP line-manager relationships • Ability to work with CTOMs, Clinical Study Teams, investigators, and internal and external stakeholders • Ability to support site audits and inspections and resolve findings • Ability to follow ICH-GCP and BeOne standards

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness