Regional Clinical Study Manager

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $118.6k - $158.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 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

• Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget • Lead the regional clinical operations team and oversee external regional partners • Act as escalation point for regional study issues • Align regional deliverables with overall study goals • Lead regional operations meetings and represent the regional study team at internal and cross-functional meetings • Plan and manage assigned clinical studies from feasibility through regional closeout • Generate, manage and maintain regional study start-up and recruitment timelines • Drive trial feasibility, country allocation and site selection with relevant stakeholders • Provide regional input on global study plans • Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions • Ensure study submissions in assigned countries in collaboration with study start-up and regulatory teams • Maintain regional and country information in study systems and tools • Collaborate with CRAs on site execution and review/sign off monitoring reports • Ensure country and site-level Trial Master Files are created, maintained and quality-checked • Provide input on regional drug inventories, local drug labels, comparator drug approvals and reimbursement status • Manage regional trial data collection, data entry and query resolution • Support Clinical Study Report planning and execution • Handle escalated site issues and monitor compliance with protocols, SOPs, ICH/GCP and regulations • Ensure regional inspection readiness and implement solutions to study issues • Prepare sites for audits and inspections and drive responses to findings • Share learnings and best practices across teams • Lead improvements and contribute to work instructions and SOPs • Select and manage regional study vendors with sourcing • Manage regional study budgets • Coordinate investigator fees, site payments and patient travel reimbursement • Identify regional resource needs and contingency plans • Monitor regional resource utilization • Provide performance feedback and mentor junior team members as needed

🎯 Requirements

• 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry • Proven experience in clinical research, including relevant experience as team lead in clinical functions • Experience as CRA is preferred • Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • MS Office proficiency • Project Planning Applications proficiency • Knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs and applicable regulations • Ability to travel as required by business need

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Reasonable accommodation for applicants with disabilities