Search Jobs
Clinical Documentation Specialist II
Job Description
*Depending on experience
100% remote
Manage Phase I to IV study activities. Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines. This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.
Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines. This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.
1. Bachelor's degree or international equivalent preferred. Minimum 2 years relevant industry experience in clinical document management or equivalent experience preferred.
2. Demonstrates analytical and critical thinking skills.
3. Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
4. Demonstrates awareness of clinical documentation business procedures. Compliant to clinical documentation processes
?5. Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred.
*CO/NYC candidates might not be considered
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.
Share This Job:
Related Jobs:
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.