Beacon Hill Pharma Lenexa, KS
- Expired: over a month ago. Applications are no longer accepted.
- Job Description:
- Supports the life-cycle management and associated processes from study set-up to archiving of the Trial Master File (TMF) according to clinical standards, practices and regulations.
- Sets up the TMF per client-approved specifications and company standards by receiving all study documentation and logging information to the correct location within the appropriate tracking system.
- Ensures files are thorough and complete through the maintenance of the study folders, application of study-specific labels, assessment of supply needs for each aligned project and review of content compliance.
- Reviews documents for key identification attributes and, if required, edits and communicates adjustments to data.
- Interprets TMF specifications on proper disposition of documents. Assists with special projects related to the TMF such as file location organization, archived study maintenance, etc.
- May review and prepare the TMF for audits / reviews and resolves any internal quality control and/or audit findings.
- May Prepare the TMF for delivery at study closeout and ensures proper archiving of study documents is completed.
- May run and maintain departmental and/or sponsor requested reports to ensure accuracy.
- Knowledge, Skills, and Abilities:
- Basic knowledge of the documents in the Trial Master File
- Basic knowledge of ICH/GCP, local regulatory authority and clinical development regulations
- Good written and verbal communication skills
- Good Microsoft Office and record management system skills
- Basic ability to use established processes and systems to maintain the Trial Master File
- Problem Solving:
- Problems are defined and readily apparent. Selects the best option from a set of defined procedures, standard practices or instructions. Solution is generally readily apparent and can be applied quickly. Work is reviewed regularly.
- Displays common courtesy and politeness. Nature of communication follows a routine pattern.
- Supports the achievement of goals through personal effort in own work area. Impact focused on the immediate delivery of tasks.
- Minimum Qualifications:
- What do you need to have?
- High school diploma or international equivalent
- 2 years of relevant experience
- What do you need to have?
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Beacon Hill PharmaWhy Work Here?
Exciting Biotech company with many life saving developments in progress! This is a great culture and a winning team that you would love!
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
HealthcareView all jobs at Beacon Hill Pharma