The Area Study Start Up (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 US/PR and LATAM. The role works cross-functionally with the Global Study Start Up Lead, Country Study Start Up Specialist, and Study Team involving start up, execution, and close out. The Area SSU Lead drives deliverables by usage of innovative approaches, active analysis of Key Risk, metrics, and milestones using dashboards and reports. Will deliver start up focused strategic input on country strategy, start up timelines, site profiles and risk assessment for the area. The role reports into the Area SSU Lead Head and serves as a single point of accountability across the area for delivery and execution of the site start up and maintenance activities for the assigned studies within the area.
Note: Area SSU Lead will report into the Area SSU Head but have an operational reporting ling to the Global SSU Lead. In the US, the Area SSU Leads will report in through the Area SSU Clinical Operations Manager, who report into the Area SSU Head.
Primary responsibilities include but are 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
Key Stakeholders: Clinical Development, Clinical Program Development, Global Site Contracting & Purchasing and Supplier Management, Area and Affiliate Regulatory, Clinical Trial Submissions Group, Legal, Safety, OEC, CDC, Global Medical Affairs, Global SSU, DDC, Agility and Innovation
- 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, 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 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
Significant Work Activities: Keyboard use (greater or equal to 50% of the workday)Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced