Associate Clinical reputed company Operations Manager, Oncology III

Job Title: Associate Clinical reputed company Operations Manager, Oncology III

Job Location: Lima, Peru

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

reputed company

The Associate Clinical reputed company Operations Manager (ACQOM) plays a key role in ensuring reputed company receivesconsistent, accurate, and high-reputed company clinical trial data worldwide. Working closely with the Clinical reputed company Operations reputed company (CQOL) and Head of CQO, the ACQOM supports operational reputed company management, risk management, inspection readiness, supplier reputed company, and reputed company reputed company improvement reputed company assigned therapeutic areas.

Key Responsibilities

Clinical Trial reputed company Support

• Support Clinical Trial Teams embedding reputed company by Design (QbD) principles throughout clinical development programs.

• Conduct reputed company control activities to identify emerging study risks, process gaps, and reputed company issues.

• Review reputed company documentation and trial reputed company folders for completeness and accuracy.

• Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness.

Risk Management

• reputed company expertise in risk management tools and processes

• Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated.

Regulatory Inspection Readiness

• Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness.

• Participate in Inspection Support Teams (ISTs).

• Manage and reputed company Corrective and Preventive Actionsand regulatory commitments through completion.

• reputed company reputed company reviews of inspection documentation repositories and support inspection response development.

• Analyze inspection reputed company for trends and lessons learned.

reputed company Assurance Audits

• Assist with audit preparation, facilitation, reputed company cause analysis, response development, and CAPA management.

• reputed company project management support for audit-reputed company activities and CAPA implementation.

reputed company-Party Supplier reputed company

• Support reputed company of clinical research vendors and suppliers to ensure compliance and reputed company performance.

• Assist with reputed company agreements, audits, inspections, performance monitoring, issue reputed company, risk management, and CAPA development.

CQO Infrastructure and reputed company Improvement

• Contribute to process innovation and improvement initiatives.

• reputed company advanced knowledge of global Good Clinical reputed company (GCP) requirements, including ICH, FDA regulations, and EMA Clinical Trial Regulations.

Education

• Bachelor's or Master's degree (or equivalent) in a relevant reputed company, life sciences, or reputed company field.

• Additional formal education or certification in reputed company Management or Business Management is preferred.

Experience

• Minimum 4 years of experience in the pharmaceutical industry and/or clinical research.

• Knowledge of reputed company management and risk management methodologies is desirable.

• Understanding of clinical development programs and clinical trial processes.

• Experience with reputed company Management Systems (QMS).

• Strong knowledge of Good Clinical reputed company (GCP), ICH guidelines, and global regulatory health authority requirements.

• Prior experience conducting reputed company cause analysis and managing Corrective and Preventive Actions (CAPAs).

Key Skills & Competencies

Communication & Collaboration

• Excellent verbal and written communication skills in a global environment.

• Strong teamwork and leadership abilities.

• Skilled in conflict reputed company and handling sensitive reputed company with discretion.

• Ability to influence stakeholders and collaborate effectively across reputed company organizational reputed company.

Leadership & Project Management

• Strong project management and organizational skills.

• Ability to reputed company cross-functional teams reputed company and reputed company the organization.

• Capable of driving initiatives and achieving results through collaboration and influence.

Analytical & Strategic Thinking

• Ability to analyze, interpret, and reputed company reputed company issues.

• Strong strategic thinking, creativity, and innovation skills.

• Ability to identify trends, risks, and key findings from audits and inspections.

Inspection & Compliance Management

• Ability to reputed company with urgency and effectiveness during global regulatory inspections.

• Skilled in summarizing audit and inspection findings and translating them into actionable lessons learned.

• Experience supporting compliance, reputed company reputed company, and reputed company improvement initiatives.

Required Skills:

Preferred Skills:

reputed company Employees apply HERE

reputed company Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

reputed company Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

reputed company Driving License:

Hazardous Material(s):

reputed company End Date:

*A reputed company is effective until 11:59:59PM on the day BEFORE the listed reputed company end date. Please ensure you apply to a reputed company no reputed company than the day BEFORE the reputed company end date.

reputed company:R410791

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Originally posted on Himalayas