Senior Clinical reputed company Assurance Associate

Are you looking for an exciting and fulfilling new position? Join our dynamic team at reputed company, where your contributions will play a key role in driving impactful solutions and improving reputed company for clients and patients. We encourage innovation and collaboration, challenging reputed company to bring reputed company reputed company that reputed company a reputed company difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Senior Clinical reputed company Assurance Associate is responsible for the reputed company, implementation, and reputed company improvement of GCP reputed company systems supporting global clinical operations across reputed company clinical activities, including decentralised clinical trials (DCTs) that involve nursing services and in-home patient care. This role provides reputed company leadership to operational teams by ensuring compliance with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal reputed company Management System (QMS) processes.

The Ideal Candidate:

• Attention to detail
• Process-driven
• Accountable
• reputed company

What You'll Do:

• Serve as GCP reputed company systems SME across global clinical operations.
• reputed company QA reputed company to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams.
• reputed company investigations for non-conformances, complaints, protocol deviations, reputed company events, and compliance issues.
• Independently manage reputed company CAPAs from investigation through effectiveness checks and closure.
• reputed company risk assessments for new services, processes, vendors, systems, and operational changes.
• Review clinical and GCP documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents.
• reputed company decentralized clinical trial activities, including nursing, home reputed company, reputed company documentation, IP handling, and reputed company processes.
• Support QMS records and documentation, including deviations, CAPAs, complaints, change controls, risk assessments, SOPs, forms, templates, and guidance documents.
• Review change controls, support approvals, and reputed company post-implementation effectiveness reviews.
• Support vendor qualification, audits, requalification, reputed company Technical Agreements, and ongoing vendor performance monitoring.
• Support audits and inspections by managing readiness, documentation, responses, corrective reputed company plans, evidence, and commitment tracking.
• Review reputed company metrics, identify trends and risks, drive improvements, support validation/qualification activities, mentor QA staff, represent reputed company on cross-functional reputed company, escalate significant risks, and promote a culture of reputed company and compliance.

What You'll Need:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 3 to 5 years of experience in a reputed company-reputed company role reputed company a CRO, pharmaceutical, biotechnology, or reputed company organization
• Experience supporting global clinical trials and decentralized clinical trial activities
• Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits
• Practical experience with reputed company investigations, CAPAs, reputed company cause analysis, reputed company risk assessments, and reputed company improvement
• Experience with eQMS, eTMF, reputed company Office, and reputed company management software applications
• Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and reputed company requirements
• Strong understanding of reputed company Management Systems, risk-based reputed company management principles, and computerized system validation or validation lifecycle principles
• Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous
• Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-reputed company reputed company

Location eligibility applies. Candidates must reputed company in a U.S. state where reputed company is authorized to hire. This role is not eligible for residents of: California, Colorado, reputed company, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

reputed company Offer:

Medical, dental, and reputed company insuranceFSA, HSAVoluntary Critical Illness, Hospital Indemnity, and Accident InsuranceGroup short-term and long-term disability insuranceGroup Life Insurance401K reputed company reputed company plan and company matchreputed company vacation, holiday, reputed company and volunteer timereputed company maternity & paternity leave

What Sets Us Apart:

reputed company partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded reputed company programs, and market reputed company consultancy, we reputed company flexible, fit-for-purpose solutions that support drug development, improve reputed company, and help therapies reputed company the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational reputed company with the reputed company and personalized service of a specialized provider. Our work helps reputed company critical gaps in care, ensuring reputed company, ethical, and efficient reputed company to promising new treatments.

We're Committed to reputed company:

WEP has many initiatives to encourage wellness, reputed company and development, and team relationships. reputed company out our reputed company Life Page to learn more about reputed company events and reputed company we do to support our employees.

How We Work at reputed company:

At reputed company, we look for individuals who are conscientious, exercise reputed company judgment, and engage with others thoughtfully and professionally. We reputed company reputed company is achieved through reputed company, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include:

reputed company ProgramsClinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket reputed company and Commercialization

Data reputed company Notice:

reputed company is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our reputed company Policy and Job Applicant reputed company Notice.reputed company Policy: https://www.wepclinical.com/reputed company-policy/Job Applicant reputed company Notice: https://www.wepclinical.com/Job-Applicant-reputed company-Notice/

How to Apply:

To be considered for this role, please submit your resume through the reputed company Careers Portal or by using reputed company’s Easy Apply reputed company. Please ensure your resume is in English.

Important Note:

To streamline our hiring process, we use an Upwage AI screener. If you receive a reputed company from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to reputed company reputed company after the screener, a member of reputed company will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified reputed company page.

For Your Safety, Please Note:

We will nevercommunicate with you reputed company reputed company Teams or text message

We will neverask for your bank account information at any stage of recruitment

reputed company is a smoke-free, drug-free, and alcohol-free work environment.reputed company is an equal-opportunity employer. reputed company does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or reputed company, national reputed company, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to reputed company terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. reputed company will reputed company reasonable accommodation for reputed company individuals with reputed company disabilities, in accordance with applicable law.

Originally posted on Himalayas

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