Global Study Start Up Lead IV

Job Description:

The Global Lead, Study Start Up is the single point of accountability for defining start up strategy and executing the global country and site activation plans for a designated Therapeutic area.

Job Duties:

• Providing start up focused strategic input on the study plan, country strategy, start up timelines, site profiles and risk assessments for their assigned TA and/or Indication
• Establishing global activation plans in partnership with SSU Area Leads and Site Monitoring Leads, including risk assessments and mitigation planning
• Driving alignment with Clinical Trial Submissions and Regulatory on global submission strategy to assure coordination with EC submissions, contract execution and activation planning
• Driving standardization in global start up process and training, including sharing of best practices and lessons learned
• Monitoring start up progress against established Start Up KPIs and Milestones
• Overseeing SSU Area Leads and Specialists from an operational perspective for their assigned trials
• Partnering with Clinical Program Leadership and Clinical Site Management TA Leads to facilitate cross-functional communication and collaboration
• Supporting the development and maintenance of SOPs, tools, and templates for study start up activities
• Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
• Participating in process improvement initiatives as required

Qualifications:

• Bachelor's Degree required, degree in health care or scientific field preferred
• A minimum of 3-6 years of global study start up and clinical project management experience and thorough knowledge of global clinical trial regulations and processes
• Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving company's leadership attributes.
• 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 start up execution and aptitude for managing multiple priorities in a fast-paced environment
• Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment

Additional Skills & Qualifications:

• study start up, global experience

Experience Level:

Intermediate Level

Location: FULLY REMOTE

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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.