Regional Clinical Trial Management Associate

3+ years

$65,000 - $90,000 annually

Remote

10 Aug. 14, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Study Support Specialist

Location: BeiGene, Global (Remote with occasional travel)

Company Overview:

BeiGene is expanding rapidly and offers dynamic opportunities for experienced professionals passionate about advancing cancer treatment. We seek motivated, collaborative individuals with a deep commitment to scientific and business excellence.

Position Summary:

The Clinical Study Support Specialist assists the Regional Clinical Study Manager in delivering regional clinical studies by ensuring the execution of delegated study components meets quality standards, timelines, and budget constraints. This role supports Clinical Research Associates (CRAs) and Study Start-up Specialists (SSUSs) in country-specific study delivery and builds knowledge of clinical trial operations in the region.

Key Responsibilities:

Regional and Country Study Support:
- Develop regional study management skills by overseeing feasibility assessments, study start-ups, document generation, and participant enrollment.
- Assist CRAs and SSUSs with CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance.
Collaboration and Coordination:
- Support the Regional Clinical Study Manager in setting up regional team meetings and Country Heads in organizing country team meetings.
- Foster collaboration with stakeholders regionally, globally, and at the country level.
Documentation and System Management:
- Create and maintain SharePoint folders and study distribution lists.
- Set up countries and sites in systems like eTMF and CTMS, and manage system access requests.
- Assist in the local adaptation of global documents and review study-related documents as needed.
Operational and Quality Support:
- Help resolve regional/country-specific issues related to clinical supplies and support data cleaning activities.
- Prepare site newsletters and correspondence related to clinical trials and assist in maintaining public registry information.
- Identify operational risks and recommend solutions in collaboration with the Regional Clinical Study Manager.
Budget and Vendor Management:
- Assist with vendor setup, regional study budget management, PO setup, and payment follow-ups.

Required Qualifications:

Education: Bachelor’s Degree preferred.
Experience: 3+ years in a scientific or healthcare discipline; at least 1 year in clinical research within biotech, pharma, or CRO industry.
Skills:
- Proficiency in MS Office, eTMF, and CTMS.
- Knowledge of clinical operations methodologies and clinical study processes.

Competencies:

Fosters Teamwork: Collaborates effectively with diverse teams.
Provides and Solicits Honest Feedback: Shares and receives constructive feedback.
Self-Awareness: Understands and manages personal strengths and weaknesses.
Acts Inclusively: Promotes an inclusive environment.
Demonstrates Initiative: Takes proactive steps in assignments.
Entrepreneurial Mindset: Shows innovation and resourcefulness.
Continuous Learning: Seeks ongoing development opportunities.
Embraces Change: Adapts to evolving situations and challenges.
Results-Oriented: Focuses on achieving goals and objectives.
Analytical Thinking/Data Analysis: Interprets complex data and derives insights.
Financial Excellence: Manages budgets and financial aspects effectively.
Communicates with Clarity: Delivers clear and concise communication.

Salary Range: $65,000 - $90,000 annually. Compensation is determined by factors such as skills, experience, education, and location. The listed range reflects base salary only; employees may also receive annual bonuses and equity awards. Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.

Equal Opportunity Statement:

BeiGene is committed to diversity and equal opportunity. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. Employment decisions are based on qualifications, merit, and business needs.

Apply Now:

Join us in our mission to revolutionize cancer treatment and make a significant impact on patient lives. Apply today to be part of our innovative team.

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Regional Clinical Trial Management Associate

Job Description

Clinical Study Support Specialist

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