Study Start Up Lead (Remote)

25 Nov 2024

Vacancy expired!

STUDY START UP LEAD (REMOTE) IRVINE, CA Remote position. Project Description:

  • The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area.
  • The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area.
  • Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads .
  • Overseeing and proactively driving activities of Country SSU Specialists for assigned trials.
  • Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
  • Working with Area and Country leadership to identify training needs of the country start-up specialists and standardizing and facilitating training solutions for Start-up specialists within area.
  • Accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned clinical studies within area .
  • Working collaboratively with key stakeholders and establishing country/site activation plans including risk assessments and mitigation planning for the countries and sites within their area .
  • Driving start up activities including timely site selection and activation, EC submissions, document collection, and query responses.
  • Providing area start up updates and metrics to Area Director, and Global SSU Leads
  • Running area start up meetings and driving priority action items between meetings .
  • Collaborating with Global Site Contracting & Purchasing and Supplier Management, CTS, and Regulatory Affairs, Global SSU Leads, Global CSM Leads, Country COMs and Country SSU Specialists to assure alignment between contract execution, CA and EC submission activities, site training visits and site activation planning .
  • Leading quality management through risk-based thinking for the assigned studies .
  • Driving standardization in area start up process and training, including sharing of best practices and lessons learned .
  • Maintaining SSU performance metrics and KPIs for assigned studies .
  • Ensuring audit/inspection readiness .
  • Ensuring maintenance of intelligence database and Vault EDLs for countries and sites within their area .
  • Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines .
  • Participating in process improvement initiatives as required .
Required Skills:
  • Bachelor's Degree required, degree in health care or scientific field preferred .
  • A minimum of 6 years of clinical research experience and preferably 4+ years of study start up management experience for the designated region.
  • Must have hands on experience in interpreting regional clinical research regulations and processes.
  • At least 2 years of experience in line management of people, coaching and mentoring of staff and teams preferred.
  • Proven leadership skills in a cross-functional global team environment, experience in working with remote/virtual teams, and an ability to influence and align stakeholders in a cross-functional, multi-cultural environment .
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
  • Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
  • Demonstration of successful program execution, preferably in startup, and aptitude for managing multiple priorities in a fast paced environment .
  • Advanced working knowledge of ICH and Google Cloud Platform guidelines and operational understanding of the area regulatory environment .
This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-04102 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #LI-BB1

  • ID: #23461456
  • State: California Irvine 92612 Irvine USA
  • City: Irvine
  • Salary: BASED ON EXPERIENCE
  • Job type: Contract
  • Showed: 2021-11-25
  • Deadline: 2022-01-23
  • Category: Et cetera