About LanceSoft:
Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services companies. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client’s requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft's dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.
I look forward to work with you and encourage you to visit our website www.LanceSoft.com to learn more about LanceSoft as an organization.
Job Description
The incumbent is responsible for, but not limited to the following:
- Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
- Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
- Perform literature search and data analysis to address research questions
- In collaboration with other clinical staff and/or an external CRO, monitor clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
- Assist in database cleaning, review of study results, and interpretation of results
- Adhere to key performance indicators for clinical study development, conduct, and reporting
- Present concepts, facts, and reports and advise on key trends and issues
- Troubleshoot routine site inquiries
- Support the planning, execution and reporting of clinical programs/trials
- Handle multiple protocols simultaneously
- Contribute to risk resolution by escalating and monitoring project risks
Minimum Requirements
• Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry
• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area
• Bachelor’s Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
- Bachelor’s Required. Doctoral (PharmD or PhD) degree preferred
- Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry
Additional Information
All your information will be kept confidential according to EEO guidelines.
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