Full Time

Area Study Start Up Lead

Posted 2 months ago
Application ends: October 29, 2021
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Job Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose: 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.

Note: Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.

Primary Responsibilities Include But Not Limited To

  • 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
  • building country level ICF samples, reviewing IRB/EC comments on ICFs and routing for approval by required functional areas (as required by region)
  • 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

Qualifications

Qualifications

  • 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.
  • Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).
  • 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, multicultural 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 start up, and aptitude for managing multiple priorities in a fast‐paced environment
  • Demonstration of participating in successful initiatives, special projects, and activities that support the business
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the area regulatory environment

Travel

Yes, 5 % of the Time

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.