Global Document Specialist (GDS) TMF
Duties & Responsibilities
- Verifies availability, correct and timely filing of Trial Master File (TMF) for the Region; archives TMF in the Electronic Document Management System for Submission Documents (e. g. BIRDS)
- Performs content checks within files and plausibility checks between files, including financial disclosure forms and OPU/Trial tabulations; Cross checks completeness with other data sources (e. g., 1572s,CTMS) for the Region
- Works with LDS to address open issues and ensures any required corrections are made.
- Provides TMF status reports to demonstrate TMF completeness and quality.
- Reviews regulatory documents to ensure completeness in accordance with ICH/GCPs, FDA Regulations, including other health authorities.
- Support inspection readiness activities, including driving documentation required to reconstruct a clinical trial.
- Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the TMF Management group to deliver value and enhance overall operational effectiveness.
- Actively remains current with industry standards, trends, and competitive intelligence on TMF management best practices.
- Maintains close relationships with Global Head Documentation Management, Study Management & Conduct, Site Enablement, Site Feasibility and Recruitment & Retention, CO Training and Compliance, CDMA, Regulatory, Legal, Investigational Sites, Clinical Research Organizations, and third-party vendors to assure a closely coordinated program based on common objectives.
- Represents TMF documents processes on local/global working groups.
- Ensures commitment to customer-centric behaviors: provides visibility to trial teams and broader Clinical Operations into ongoing work through up-to-date tracking; maintains high degree of responsiveness to both internal and external requests; resolve issues by working collaboratively across Clinical Operations and other groups within BI.
- Develops and delivers appropriate training for the TMF Management group in partnership with the Training and Compliance group.
- Bachelor's Degree from an accredited institution (preferred major/focus: Health Sciences) and three-plus (3 ) years of experience; or six-plus (6 ) years of equivalent experience.
- Requires a solid understanding of CTMF requirements and SOPs, system functionality, and practices.
- Track record in setting priorities, organization and problem solving skills which support and enable sound decision making.
- Excellent customer service skills and high attention to detail.
- Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.
- Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.
- Ability to travel domestically as needed.
- Ability to use and learn system applications, e.g., MS Office, document management systems, etc.
- Demonstrated experience in the regulated pharmaceutical or healthcare industry.
- Thorough understanding of all phases of drug development (I-IV).
- Understanding of federal regulations pertaining to IND and NDA regulations.
Desired Skills, Experience and Abilities:
- Experience in archiving and retrieval systems is preferred
- Experience in regulated pharmaceutical or healthcare industry is preferred
- Familiarity with CTMF requirements and SOPs, system functionality, and practices is preferred
- Must be legally authorized to work in the United States without restriction.
- 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 one of the world's top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. 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. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 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 verifications and drug screenings.