Area Study Start-up Lead (EN)

工作内容

Do you have a Degree in health care or scientific field? A minimum of 6 years of Clinical Research experience and preferably 4+ years of Study start-up management experience? Also at least 2 years of experience in Line Management of people, coaching and mentoring of staff and teams and you are fluent in English? Then we may have your dream job!

Job Description

The Area Study Start-Up 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 Site Start-Up 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 Study Start-Up Lead 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.

Responsibilities

• You oversee and proactively drive activities of Country Site Start-Up Specialists for assigned trials.
• You proactively identify and communicate issues impacting delivery and providing proposed solutions.
• You work 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.
• You are accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned clinical studies within area
• You work collaboratively with key stakeholders and establish country/site activation plans including risk assessments and mitigation planning for the countries and sites within their area
• You build country level ICF samples, reviewing IRB/EC comments on ICFs and routing for approval by required functional areas (as required by region)
• You drive start up activities including timely site selection and activation, EC submissions, document collection, and query responses,
• You provide area start up updates and metrics to Area Director, and Global SSU Leads
• You run- area start up meetings and drive priority action items between meetings
• You collaborate 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
• You lead quality management through risk-based thinking for the assigned studies
• You drive standardization in area start up process and training, including sharing of best practices and lessons learned
• You maintain SSU performance metrics and KPIs for assigned studies
• You ensure audit/inspection readiness
• You ensure maintenance of intelligence database and Vault EDLs for countries and sites within their area
• You ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
• You participate in process improvement initiatives as required

Requirements

• 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
• Existing right to work in Europe required

Benefits

• Full-time position
• Balanced salary package based on your capabilities and experience

Vacancy number: 18889