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Sr Analyst, Clinical Operations
Job Description
Summary:
The main function of a clinical operations analyst responsible for efficient processing and quality check of all study documents.
Key Responsibilities:
• Conduct periodic audits of documentation and may participate in internal master file audits
• Review and ensure accuracy and completeness of clinical study files and/or device accountability logs, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• May be required to work in the coordinator role as dictated by business needs
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Other incidental duties (e.g. occasional photo copying or deliveries)
Additional Skills:
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast paced environment
• Substantial knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Must be able to work in a team environment under minimal supervision
• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Education and Experience:
• H.S. Diploma or equivalent
• 5-7 years of experience required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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