At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.

Parexel FSP is recruiting for a Global Site Management Manager (Senior COL) based in Serbia/ Poland/ Romania. Home based role. Dedicated to a single sponsor.

You will support the delivery and oversight of the sponsor's clinical trial portfolio of studies. Responsibilities can include, developing study-specific monitoring strategy, critical data TSDV specifications, ensuring critical data SDR approaches, review CRO bids and strategy proposals, completing monitoring plan reviews, and acting as an RBQM subject matter expert to both internal and external stakeholder groups.

The role collaborates with Clinical Trial Management study teams to design fit-for-purpose monitoring strategies, including supporting study risk assessment activities aligned with RBQM methodology.

The incumbent will also support oversight of Functional Service Provider (FSP) vendor(s) and CRO Monitoring and Site Management deliverables. Activities can include tracking performance and quality through review of performance metrics and risk indicators. In addition, the role may also support process improvement initiatives as needed. 

We will offer you exceptional financial rewards, training, and development.

Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.

Tasks on the role

• Creates a study specific monitoring strategy which includes, but is not only limited to the identification of critical data and process, consulting on data review methods (including Key Risk Indicators and appropriate detection approaches) and the study specific monitoring visit strategy
• Provides monitoring functional expertise to support study budget planning as well as subsequent change orders and ongoing study budget assessments
• Ensures translation of derived monitoring strategy into Clinical Monitoring Plan
• Creates tSDV specifications in collaboration with CROs , Clinical Study Teams and Data Management
• Participates in Clinical Study Team Meetings and Quality Review Meetings providing input to study teams on existing and emergent operational risks as needed
• Supports all REGN site management activities to ensure compliance to the protocol, monitoring plan, ICH GCP, REGN SOPs, and local operational and regulatory requirements (SQV, SIV, IMV and COV)
• Provides support of oversight of CRO partner site management activities, including CRO CRA engagement activities, review of CRO CRA resource allocation and performance
• Supports Sr. Manager to oversee FSP CRAs to ensure sites meet performance expectations related to study delivery, including subject identification, enrollment, retention, and timely delivery of quality data
• Support performance management and oversight of FSP and CROs through pro-active monitoring of metrics and KPIs, including oversight of onboarding activities
• Supports inspection readiness activities and participates in Regulatory GCP inspections and/or audits
• Acts as a subject matter expert (SME) and REGN point of contact for monitoring/site management topics
• Identifies issues and applies knowledge, prior experience and critical thinking to make decisions; escalates site management-related issues as necessary
• Maintains regular communication with key cross functional counterparts and participates in applicable forums/meetings to optimize performance and delivery at investigator sites (eg. CTM, GTO, SSU, VRM)
• Participates in process improvement initiatives

Requirements:

Knowledge and Experience:

• 5+ years of experience as CTM or COL managing global studies.

Skills:

• Experience of working in a risk based quality operating model
• Knowledge of the drug development process and specific knowledge of clinical trial operations, clinical monitoring and site management process, and associated industry regulations
• Familiarity of medical terms
• Excellent interpersonal skills and demonstrated collaborative as well as independent working style
• Ability to build relationships with internal stakeholders
• Ability to translate a design strategy into an operating framework
• Critical thinker
• Proactive and self-motivated
• Strong organizational skills with effective use of time and prioritization
• A working knowledge of ICH/GCP
• Up to 25% travel required

Education:

• Bachelors Degree
  
  

For more details contact marta.kuniewicz@parexel.com