24 days old

Manager, Clinical Operations - Study Start-up

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    200134

Manager, Study Start-up

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Manager, Study Start-up partners closely with the Study Start-up and Patient Recruitment team, Clinical Operations team members, CRO partners and internal Expertise Areas to drive top quartile, best in class delivery and optimzation of study start-up and enrollment milestones. He/she provides oversight and support to study teams for country and site feasibility, data-driven scenario planning and start-up and enrollment forecasting to ensure predictable and consistent delivery.

The Manager, Study Start-up will serve as an expert in study start-up practices by applying efficient implementation of appropriate processes, tools and technologies to accelerate start-up activities and by removing obstacles for study teams. He/she will share best practices within his/her team and across the Clinical Operations organization to deliver consistent application of these practices.

Summary of Key Responsibilities

  • Participates in the early strategic planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable
  • Manages data-driven approaches to 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; ensures timely site activation and facilitates timely resolution to remediate issues by utilizing in-country intel and expertise to remove or prevent roadblocks
  • Partners with CRO to harness historic study/site performance data, 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 collect local intel on country/site selection; utilize historic country/site-specific performance data and documentation (e.g. previously negotiated clauses) to facilitate expedited start-up activities
  • Tracks and reports relevant KPIs/metrics including local country cycle times to support process improvement and overall operational/business reporting
  • 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 (3 years) managing operational aspects of clinical studies. Significant experience in study start-up 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.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.





Posted: 2021-03-26 Expires: 2021-04-24
Sponsored by:
ADP Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager, Clinical Operations - Study Start-up

Alnylam Pharmaceuticals
Cambridge, MA 02139

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast