ACS Solutions has an immediate need for a Study File Specialist/Clinical Study. This is a 12+ months contract opportunity (with long-term potential) and is in Cambridge, MA. Our client is a leading [Air Lines] company. Please review the job description below:
Top Skills: [ETMF, Clinical Study and Clinical Review]
The Study File Specialist will provide support for Trial Master File (TMF) activities to the clinical teams.
This role will be responsible for working with study teams, both internal and external, perform document review in *** eTMF, assist with training and implementation of the eTMF and complete TMF completeness checks for assigned trials.
General activities include, but are not limited to: review of TMF processes and system for continuous improvement, continued relationship building with key stakeholders and customers, and assist *** study teams with inspection readiness activities.
1. Excellent written and oral communication skills and strong interpersonal skills
2. Possesses excellent time management and organization skills
3. A commitment to producing high quality work product with attention to detail
4. Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines and complex clinical studies
5. Proficiency in MS Word, PowerPoint, Excel, Adobe. Experience in Veeva Vault eTMF is a plus.
Thanks & regards,
ABOUT ACS SOLUTIONS. ACS Solutions is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies: * AIC
Recent Recognitions: #No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero s Best of Staffing Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing Client Diamond Award Winner(2017) Website: www.acsicorp.com