Manager, Clinical Operations Study Start-up

Overview

Alnylam Pharmaceuticals is seeking a Manager, Study Start-up to join our dynamic and growing team. The Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III clinical trials. This team member will also partner closely with CRO partners, internal study stakeholders, KOLs, external vendors, and site networks to drive top quality, best in class delivery, acceleration and optimization of study start-up, site activation and enrollment milestones. The Manager, Study Start-up provides direct oversight, direction, and support beginning at early study planning, country and site selection, feasibility, data-driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery.

The Manager, Study Start-up will serve as an expert across the study start-up, country, and site activation landscape. The Manager, Study Start-up practices efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities. This candidate leads successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles in order for sites to successfully activate within study and corporate objectives. The Manager, Study Start-excels in project management, organizational, and communication skills to clearly share best practices with study teams, CROs, and internal stakeholders across the Clinical Operations organization to deliver consistent application of these practices. 

Key Responsibilities

• Responsible for the oversight of global study start-up and site activation activities, milestone oversight, and CRO delivery
• Participates in the early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensures CRO commitment to all study deliverables and timelines.
• Manages data-driven approaches for study start-up including feasibility, site selection, and patient recruitment planning to increase access to the appropriate patient population
• Partners with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations
• Serves as a point of escalation for study teams and CROs; participates in timely mitigation and ensures resolution measures are being followed and completed
• Facilitates prompt risk resolution to remediate issues immediately by utilizing site and country intel, internal and external expertise to remove and prevent roadblocks
• Analyzes competitive trial performance data and industry benchmarks to support the Clinical Operations lock of baseline study milestones targets/dates; partners with CRO and internal Expertise Areas to harness historic study/site performance data as applicable
• Responsible for reviewing local country and site intel for country/site selection activities; utilizes historic country/site-specific performance data and documentation (e.g., previously negotiated clauses and approved language) to facilitate expedited start-up activities; partners with CRO and internal Expertise Areas to collect information as applicable
• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation
• Oversees consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements
• Supports the building and maintenance of study start-up, country and site activation, and patient retention and recruitment best practices
• Supports teams towards departmental and project productivity and quality metrics
• Supports the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency

Qualifications

• Bachelor’s Degree in Science or related discipline.  A higher degree would be desirable.
• Significant (5+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies.
• Considerable (5+ years) managing operational aspects of clinical studies.
• Significant experience in leading global study start-up and site activation activities is required.
• Must have experience working with external CROs and cross functional teams.
• Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment.
• Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.