As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with 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, including Humira and Lupron, 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: $38.00 - 40.18 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.
qualifications:
Required Skills:
- Bachelor's degree or international equivalent (preferred but not mandatory).
- Minimum 2 years of relevant industry experience in clinical document management or equivalent.
- Strong analytical and critical thinking skills.
- Excellent oral and written communication skills.
- Ability to facilitate cross-functional team meetings.
- Awareness of clinical documentation business procedures.
- Compliance with clinical documentation processes.
- Experience with Microsoft PowerPoint and Excel.
- Familiarity with Document Management Systems.
- Understanding of ICH GCP guidelines and clinical trial documentation.
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.
