Clinical Trial Master File Manager

Location
San Rafael, CA, United States
Posted
Jan 03, 2019
Ref
20383
Required Education
Bachelors Degree
Position Type
Full time
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives.

OVERVIEW:

The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, eTMF and records management, inspection readiness and response support and training development and delivery.

SUMMARY DESCRIPTION

Are you interested in Process Transformation and becoming part of a team that is leading and developing TMF strategies and best practices? We are looking for a dynamic individual who can partner with our trial team and quality team stakeholders, to advise and consult on best practices for future clinical studies. Would you be interested in leading the TMF team and developing the teams expertise?

The Sr. Specialist or Manager needs subject matter expertise within the Development Sciences Quality organization in Trial Master File (TMF) Quality and Records Management. The Sr. Specialist acts with significant independence and may be involved in more than one DSQ area.

The Sr. Specialist or Manager has foundational skills in Influencing and Leadership, and demonstrates advanced Teamwork skills. Must have foundational abilities in all DSQ technical competencies, including Quality Management and Change Management.

KEY RESPONSIBILITIES:

Adapt the responsibilities in this section to reflect the relevant content based on the nature of the hire needed.

TMF Quality and Records Management

eTMF Management
• Facilitate the creation of the enterprise and study specific TMF management tools
• Maintain TMF Management Plans and TMF Content Lists for complex studies; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
• Coordinate creation of the TMF filing locations within BioMarin based on the study specific TMF Content List
• Manage Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
• Facilitate the review and submission of TMF records to Records Management personnel

TMF-Related Collaboration & Support
• Support the coordination of the transfer of study-specific trial master files from the CRO
• Participate in Study Team meetings and provide/present regular TMF metrics updates
• Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
• Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
• Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to BioMarin processes
• Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
• Manage the TMF content list and TMF Comprehensive Review tracker
• Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management

Comprehensive Review
• Conduct quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
• Establish any corrective actions which must be addressed and assigned
• Submit documented evidence of the TMF Quality Review to the TMF
• Manage TMF documentation issues throughout the lifecycle of an assigned study

Records Management
• Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
• Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:
• Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
• Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
• Provide guidance on best practices for record handling, retrieval and archival procedures
• Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review. Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
• Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records
• Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
• Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
• Participate in the development, implementation, and maintenance of internal databases used to manage records
• Monitor and moderate access to Development Sciences records per the Records Management SOP, verifying that the processes for the management and archiving of Development Sciences records are compliant with relevant regulations
• Effectively and efficiently archive GLP and GCP records and related information from the Development Sciences organization
• Verify cross-functional alignment regarding records retention schedules and records disposition and destruction
• Work with BioMarin Facilities Operations to manage business continuity procedures, environmental controls, DevSci Central Records Room security, disaster preparedness and disaster recovery

COMPETENCIES: OVERVIEW

This section is for external use. When using this template to create an external job posting, remove the Level of Mastery Expectations tables below.

Individuals in the Sr. Specialist or Manager position are expected to demonstrate foundational Communication, Leadership, Proactivity and Problem Solving skills and advanced Teamwork skills, including:
• actively contributing to team definition of goals, roles and tasks
• proactively expanding one's network and work relationships outside the department
• ability to create inclusive and collaborative team and meeting environments
• ability to recognize, articulate and prioritize key issues that arise based on understanding of objectives
• ability to analyze and evaluate problems and seek out and recommend possible solutions
• leveraging data effectively to communicate points of view and influence outcomes

The Sr. Specialist should demonstrate foundational skills in all DSQ technical competencies, including Process Analysis, Change Management, and Training Management. Capabilities include:
• an ability to identify bottlenecks or inefficiencies in a process, as well as consumer needs, and alert the appropriate stakeholders
• an ability to support change management processes by ensuring buy-in, readiness, and understanding among participants and stakeholders
• an ability to organize and prioritize training communications content, ensuring inclusion of essential material while maintaining brevity where needed

COMPETENCIES: LEVEL OF MASTERY EXPECTATIONS

This section is for internal use.

BioMarin has defined core and technical competency expectations for each title within DSQ. These expectations are outlined in the Competency Matrices.

Please refer to the matrices and detailed levels of mastery descriptions for more detail.

Below is a high level summary of the core and technical competency expectations:

Mastery (M) : Extensive, expert-level understanding and proven performance in the skill area

Advanced (A) : Comprehensive level of knowledge and skilled execution in the skill area

Foundational (F) : Strong baseline understanding and demonstrable implementation of the skill area

In Development (ID) : Early performance of competency and development of the skill area

Core Competencies

Technical Competencies

Leadership:

F

Regs and Good Practices: F

Communication:

F

Quality Management: F

Problem Solving and Decision Making: F

Process Analysis, Optimization: F

Influencing and Persuasion: F

Change Management:

F

Planning, Prioritization and Organization: F

Training Management (non-training roles):

F

Teamwork and Relationship Building: A

Proactivity and Initiative: F

People Management:

ID

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. For career development guidance specific to DSQ roles, please review the DSQ Career Pathway Overview.

PEOPLE MANAGEMENT

No people management responsibilities.

EDUCATION AND EXPERIENCE
• BA/BS in life sciences or technical area; experience in lieu of education may be considered
• 4+ years of relevant pharmaceutical industry experience
• Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

EQUIPMENT

Computer work utilizing common business software programs.

CONTACTS

Internal: Clinical Operations; Data Management; Pharmacovigilance; Medical Writing; Clinical Sciences; Pharmaceutical Sciences; Corporate GxP Compliance; Regulatory Affairs; TechOps Quality; Legal; Project Management; Computer System Validation Quality; IT.

External: CROs; Central Laboratories; Clinical Study Sites; Principal Investigators; other clinical vendors and suppliers

~BIO

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.