Associate Director, Clinical Document Operations Lead

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.

Summary:

The Associate Director, Clinical Document Operations Lead, is responsible for the strategic oversight and operational management of the Trial Master File (TMF) and other related clinical systems across all clinical trials. This role is the single point of accountability for TMF quality, compliance, and inspection readiness. This role ensures that TMF processes are compliant with regulatory requirements, industry standards, and company policies, with a particular emphasis on leveraging Veeva Vault eTMF systems, working in close collaboration with the Associate Director, Clinical Systems.

Essential Duties & Responsibilities:

TMF and Document Management Support:

• TMF Management: Oversee the set-up, maintenance, and quality control of the TMF for all clinical studies, ensuring compliance with ICH-GCP guidelines and regulatory requirements.
• Veeva Vault Expertise: Serve as the subject matter expert for Veeva Vault eTMF, providing guidance and training to internal teams and external partners to optimize system utilization.
• Process Development: Collaborate with Clinical Operations & Clinical Systems teams to develop and implement standard operating procedures (SOPs) and best practices for TMF management, ensuring consistency and efficiency across all studies.

• Quality Assurance: Conduct regular audits and quality checks of the TMF to ensure completeness, accuracy, and inspection readiness.

• Cross-Functional Collaboration: Work closely with Clinical Operations & Clinical Systems, Regulatory Affairs, Quality Assurance, and all other relevant departments to ensure seamless integration of the TMF processes.

• Vendor Management: Manage relationships with external vendors and contract research organizations (CROs) involved in TMF activities, ensuring adherence to company standards and timelines.

• Document Operations Leadership: Represents Clinical Operations in all document management initiatives, strategic planning, and execution of any document management plans for business-critical alignment. Prepares regular metrics and status reports on Document Control for Clinical Trial Management review. Follows up on open record management queries and ensures full resolution.

Study Support:

• Trains and mentors study teams in TMF documentation, archiving and filing.
• Provides support to clinical teams during regulatory inspections for record organization and retrieval.
• Organize and/or attend study team meetings to discuss the TMF status of each study and provide resolutions to any TMF maintenance and management-related inquiries from the study team. Escalate issues to leadership during this time, and as needed.
• In collaboration with the Clinical Trial Manager's oversight, ensures high-quality TMF management (onboarding of study contributors, completion of the TMF management plan, study-specific preparation of documents in the system, and periodic reviews).

General:

• Adhere to procedural documents and participate in reviewing, authoring, and/or updating documents reflective of industry standards.
• Develop strong and productive working relationships with key stakeholders with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
• Represent Pacira in interactions with key external partners as part of any committee or industry group relating to clinical systems.
• Participate in the development and implementation of new processes and procedures, updates SOPs as appropriate.
• As needed, accountable for the management and development of direct reports including performance management and career development.
• Supports financial management of CDO vendors, i.e., budget and invoice review, forecasting of future work, etc.
• Encourage cross-functional team collaboration for consistency across projects.

Supervisory Responsibilities:

• This position may have supervisory responsibilities

Education and Experience:

• BS/BA degree in a relevant scientific discipline required.
• Minimum of 8 years of experience in TMF Management within the pharmaceutical or biotechnology industry.
• Minimum 5 years of experience leading process management and innovation.
• Proficiency in Veeva Vault eTMF systems is essential.
• Experience leading process initiatives required.
• Excellent working knowledge of clinical study documentation.
• Strong IT proficiency with the ability to easily learn new technologies.
• Ability to clearly articulate and conduct verbal presentations with large and small audiences.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• Expertise in the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena
• Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers
• Strong project management skills
• Knowledge of FDA/ICH/GCP guidelines and industry standard practices

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.

Work Environment:

Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.