Site Activation Lead - Anywhere US

Company
Synteract
Location
United States
Salary
Competitive
Posted
28 Jan 2021
Closes
27 Feb 2021
Ref
28935
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Site Activation Lead - Anywhere, US

Remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to life TM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

As a Site Activation Lead you will provide operational expertise and leadership in the interdisciplinary planning, implementation, and management of site activation activities for clinical trials. You may be assigned to manage these activities for a specific country, region, or entire global trial.

Specific tasks would include:

  • Works in collaboration with Synteract Project Management, functional project leads (including, but not limited to: Clinical Trial Management , Feasibility, Regulatory, and Site Contracts,) and Client representatives to track and achieve the best possible site activation timelines across the project.
  • Defines and implements site start-up strategy, goals, and expectations for the interdisciplinary clinical study team.
  • Ensures completion of all site activation pre-requisites within agreed timelines (including liaising with all appropriate functional leads), monitoring team efficiency and adherence to budget and SOPs.
  • Ensures adherence to the Site Activation portion of the project budget; proactively identifies and consults with Project Management on Site Activation tasks that are out of scope.
  • Oversees the quality of and ensures compliance with project specific plans for all site activation deliverables; works with Project Management to proactively manage risks to achieve site activation targets.
  • Participates in appropriate external study meetings, including both client and investigator meetings (if applicable). Prepares and presents as required.
  • Coordinates and leads Site Start-up meetings. Prepares agenda and minutes as required.
  • Coordinates, facilitates, and conducts site activation specific training for clinical study team functional leads as required. Addresses ongoing training needs throughout the study and ensures all site activation training is documented appropriately.
  • Develops, maintains, and oversees site activation specific tools to support the clinical operations team.
  • Effectively interprets and reports on site activation progress and associated metrics to all relevant stakeholders.
  • Communicates with the Project Manager, Functional Lead, and Client as required, escalating potential risks to site activation timelines where appropriate.
  • Provides input and support to clinical proposals, budgets, contracts, and Bid Defense Meetings, including attendance (as required).
  • Contributes to internal projects in providing site activation knowledge, feedback, and lessons learned to support process renovation projects.
  • Provides supplemental project team support, as needed, and/or as requested by Line Manager.


Qualifications
  • Bachelor's Degree or higher in a related field of study and a minimum of 5 years applicable industry experience or equivalent combination of education and experience.

Specific Knowledge
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Working knowledge on Global clinical studies, and demonstrated ability to understand regulations and challenges in site activation for international studies.
  • Thorough knowledge of clinical research process.

This job excludes Colorado applicants.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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