A research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!
location: Telecommute
job type: Contract
salary: $38 - 40 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- 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.
- TMF Management from study initiation through archival post-CSR publication.
qualifications:
Required Qualifications
- Bachelor's degree or international equivalent preferred.
- Minimum 2 years pharmaceutical industry experience in clinical document management
- Demonstrates analytical and critical thinking skills.
- Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
- Demonstrates awareness of clinical documentation business procedures.
- Compliant to clinical documentation processes
- Vault experience
- Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred
- Understanding of ICH GCP guidelines and clinical trial documentation.
- Inspection background or experience with inspection readiness.
- Familiarity with TMF management plans.
- Vendor management experience.
skills: Phase I, Phase II, Phase iii, Phase iv, GCP (Good Clinical Practice), ICH Regulations, TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
