The Associate Director, Clinical Operations (TMF, CTMS) is responsible for managing the day-to-day operations of important clinical systems (Trial Master File and Clinical Trial Management) that support clinical trial execution.

The individual participates in and leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Clinical Development (focus on Clinical Operations).

The individual will function as a Clinical Operations team leader accountable for talent acquisition, development, line management, and evaluation of team members in his/her/their group. This includes responsibility for the ‘What’ (delivery to performance goals) and the ‘How’ (deliver consistent with Alnylam core values).

The individual is a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients.

This position reports to a Director, Clinical Operations.

Key Responsibilities

• Oversee building capabilities, implementation and maintenance of CTMS and TMF systems in support of related processes.
• Lead the creation and delivery of system related training.
• Ensure system administrative and study-related set-up activities are defined, appropriate and carried out in a timely manner
• Oversee system user access management
• Collaborate with system and technology team to support data aggregation and reporting
• Lead an ongoing community of practice and functional superusers for CTMS
• Ensure the system and associated activities are managed within budget/resource
• Actively support the strategic vision for CTMS and TMF to maximize end user focus and engagement
• Partner with key internal and external stakeholders to remediate risks and manage emerging issues
• Use proactive approaches to process improvements and enhancements of CTMS and TMF capabilities and standards
• Lead and manage system related change control activities
• Foster best practices, mentor and consult on CTMS and TMF across the Development and Operations organizations
• Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for CTMS and TMF
• Provide expert support for CTMS and TMF audits and inspections
• Participate as an active member of the Clinical Operations Extended Leadership Team (XLT)
• Promote a culture of continuous improvement; acts as a change champion and effectively leads change
• Other key assignments including ad hoc and assignments in support of Clinical Operations and clinical trial execution.
• Travel on assignment, ≤ 25%

Skills

• Detail-oriented with strong organizational abilities with an ability to multi-task, be flexible, and thrive in a fast-paced team environment.
• Excellent interpersonal, verbal, and written communication skills, including experience in delivering presentations and training sessions.
• Extensive demonstrable related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment.
• Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to clinical systems.
• Continuous improvement mindset and ability to function independently with a proactive attitude and the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
• Willingness to work effectively in a matrix environment and value the importance of teamwork.
• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations.
• Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines
• Proficient in common office technology e.g., Microsoft tools, teleconferencing, etc.

Requirements

• University degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred
• Strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS)
• Proven matrix and line manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff
• Experience managing clinical systems in support of Phase I – III execution of clinical trials in rare, specialty and prevalent medical conditions preferred
• Previous experience supporting regulatory inspections
• Comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations, and guidelines