Trial Master File Senior Specialist
- Alameda, CA, USA
- Location: Alameda
- Department: Development Excellence & Innovation
- Division: Drug Development
- Position Type: Regular Full-Time
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
To support the review, quality control, filling, storage, retrieval, and protection of clinical records in both paper and electronic formats, including records stored at offsite facilities, and records stored in electronic repositories. The TMF Sr. Specialist is responsible for conducting daily management activities relating to clinical study Trial Master Files (TMF), including ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manages processes and procedures for filing, retrieving, storing, preserving, and protecting clinical records.
• Collaborates with other departments where such procedures/processes overlap.
• Ensures that all records, both physical and electronic, are accurately catalogued and filed.
• Ensures that the locations of all physical records are accurately captured and that all records (paper and electronic) can be readily retrieved.
• Ensures a quality oversight process for the retrieval and processing of clinical records.
• Conducts facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluate possible options for on and off-site locations.
• Collaborates with functional groups within the company to develop, implement, and maintain a disaster preparedness and business continuity program.
• Identifies and establishes goals and objectives to support the overall goals of the company.
• Supports and facilitate any TMF remediation activities for internal sponsor TMF and CRO TMF.
• Remediates offsite archival discrepancies and establish an offsite archival database for clinical records.
• Provides mentorship and guidance to junior level staff or temporary employees
• BS/BA degree in related discipline and three years of related experience; or,
• MS/MA degree in related discipline and one year of related experience; or,
• Equivalent combination of education and experience
• 4+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 2+ year in experience using electronic records management systems, with progressive experience managing active, inactive and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures
• Stringent background in FDA regulated records management and ability to design and develop record-keeping systems, policies and procedures
• Broad understanding of business processes in a wide variety of functional areas within a large, international pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing both records and non-records.
• Expert knowledge of TMF for set-up and maintenance. Knowledge of eTMF systems are desirable.
• Background in EDC and CTMS systems desirable.
• Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.
• Excellent attention to detail, strong critical thinking, and problem solving
• Excellent organizational, time management, and project management skills.
• Strong working knowledge of GCP/ICH regulations and guidelines
• Applies technical standards, principles, theories, concepts, and techniques.
• Excellent organizational skills are required.
• Demonstrated success in problem solving.
• Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job.
• Ability to work in a team environment.
• Self-motivation, eagerness to grow professionally and commitment to self-development.
• Ability to proactively identify potential issues and formulate potential course(s) of action.
• Occasional travel may be required.
• Works on assigned problems of moderate scope with analysis of situation or data required.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal and external working relationships.
• Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.