Accurately files complex, regulatory required, documents into Clinical Trial Master File (CTMF) - a Document Management system. Coordinates with scanning group to ensure accurate filing into CTMF.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Ensures all trial documentation is prepared, accurately filed and saved into CTMF.
Liaise with trial personnel to follow-up on required documentation.
Prepares and distributes Investigator Site File (ISF) to sites.
Prepare CTMF documents for inspection readiness.
Coordinate with Document Management System support staff to ensure appropriate data dictionaries are updated for new trials.
Reconciles trial documents throughout the trial in preparation for trial close-out.
Assists in Clinical Trial Report preparation by linking appendices with Document Management System.
Performs records retention for paper documentation
Must be precise, detail oriented and able to detect subtle data inconsistencies.
Excellent verbal and written communication skills.
Demonstrated ability to read, analyze, and interpret business and regulatory information.
Very good computer skills.
Minimum of 3-5 years administrative, customer service and/or relevant business experience.
Requires a solid understanding of Clinical Trial master File requirements, Good Clinical Practices,and SOP's, document management system functionality and practices.
Demonstrates understanding of Regulatory Compliance and Record Retention policies.
Must be legally authorized to work in the United States
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Clinical Research/Medical Affairs/Drug Regulatory Affairs
BI Pharma/BI USA
As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...