Associate Clinical Trial Manager, TMF (Boston, MA) at Pharmaceutical Research Associates, Inc.
Posted in Other 8 days ago.
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Location: Boston, North CarolinaJob Description:
Pharmaceutical Research Associates, Inc.
Who are We?
We Are PRA.
We are over 15,000 employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are the TMF subject matter expert in your field, and yet, people contact you with questions that fall outside your jurisdiction because they know you will leverage every resource you have to get them the answers they need. You have excellent communication & follow-up skills, you dot your "i's" and cross your "t's," and there's just something about tasks that tap into your innate process orientation that make your heart go pitter-patter. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career.
Still here? Good. Because if this is you, we'd really like to meet you.
- Ensure TMF completeness and accuracy based on Vertex SOPs and regulatory requirements.
- Required experience with TMF/clinical study file documentation oversight and QC, Good Documentation Practice, Good Clinical Practice and strong understanding of the impact of the TMF on Trial Management.
- Possess good critical thinking skills with a focus on inspection readiness.
- Content review of a variety of documents in a short time frame while maintaining consistency and attention to detail.
- Prioritize work accordingly to meet departmental needs and independently work toward and meet deadlines.
- Generates metrics supporting TMF completeness and accuracy
- Participate in inspection readiness reviews and preparations
- The Clinical Trials Manager is responsible for independently managing Trial Master Files for assigned studies. The Clinical Trials Manager will participate in end-to-end TMF management activities, including but not limited to: TMF planning, setup, adherence to organizational TMF standards and study-level quality control reviews and facilitating issue resolution. The Clinical Trials Manager will also support the TMF Compliance & Oversight group with tracking and metrics activities.
TECHNICAL AND COMMUNICATIVE SKILLS:
- Displays sound project management skills to independently manage TMF projects with some supervision
- Demonstrates ability to communicate and coordinate activities within the group and all TMF Stakeholders
- Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
- Strong communication (written and verbal) skills
- Emerging vendor management skills
- Demonstrated computer literacy; proven functional knowledge of Microsoft packages and ability to develop
- Proficiency in relevant Vertex systems and programs
- M.S. (or equivalent experience) and 2 - 4 years of relevant work experience preferred
- B.S. (or equivalent experience) and 3 - 6 years of relevant work experience preferred
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.