Associate Director, Clinical Portfolio Services, eTMF - 13 Month Contract

Overview

The Associate Director, TMF Operations, leads the execution of Alnylam TMF operations and strategy and is accountable for the use of the TMF across the Alnylam portfolio of studies.  This role participates in the identification, evaluation, and implementation of appropriate technology and vendors to support solutions and requirements as it applies to operational execution. 

Summary of Key Responsibilities

TMF Operations Oversight

• Accountable for the oversight of the TMF Operations team supporting Alnylam’s TMF
• Ensures the effective execution of TMF Operations activities in a timely, compliant manner consistent with the Alnylam’s goals and objectives
• Manage performance, development and growth of direct reports
• Provides input to the System Owner on the use of internal and external systems for TMF records management
• Provide oversight of TMF vendors used to support operational execution
• Manage TMF Operations purchase orders as required
• Acts as main point of contact between Alnylam, CROs and other vendors as it pertains to TMF Health
• Responsible for TMF Lead tasks for specific studies as required

TMF Quality

• Ensure that processes  are followed to support high quality TMFs and inspection readiness for all studies and programs filing documents in the TMF
• Resolve or escalate study related issues that cannot be resolved by TMF Leads as appropriate
• Review standard processes and procedures to confirm their application to the Alnylam portfolio of programs and studies.
• Participate in CRO Joint Operating Committee (JOC) oversight meetings; direct TMF leads in the creation of metrics demonstrating the quality, timeliness, and completeness of TMF filing.
• Participate in audits and inspections as required and ensure observations and/or findings are addressed as appropriate; lead TMF related tasks as required
• Ensure appropriate processes are followed and budget is in place to support long term TMF archiving (paper and electronic)

Process Improvement and Training

• Work in partnership with the Process Owner and System Owner to ensure TMF Operations SOPs, Work Instructions and Templates as well as associated resources (e.g. training materials, knowledge databases) are appropriate and maintained
• Confirm training is delivered to study teams across Alnylam, CRO and Vendors on the procedures and processes related to TMF document management and quality
• Collaborate with the Process Owner to identify TMF process improvements and implement changes.
• Work in partnership with key stakeholders including the System Owner, Process Owner, Quality Assurance, Alnylam Expertise Areas and Information Technology

Qualifications and Experience:

• Bachelor’s Degree or equivalent with extensive demonstrable related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment
• Strong working knowledge of the TMF Reference model
• Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
• Must have experience of archiving, electronic document management system(s) and eTMF, Veeva Vault TMF preferred
• Experience of audits and Regulatory Agency inspections preferred
• Vendor oversight experience including contracts and budget management prefered
• Detail-oriented with strong organizational abilities with an ability to multi-task, be flexible, and thrive in a fast-paced team environment 
• Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required
• Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
• Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Previous line management experience required
• Clear alignment with Alnylam Core Values:

o Commitment to People

o Innovation and Discovery

o Sense of Urgency

o Open Culture

o Passion for Excellence