Ref #: 25334

Employment type: Fixed term - Full-Time

Location: Nederland

Posted: 06-Jan-2021

Description

We are growing our partnership with one of our top global clients – an innovative Pharmaceutical company.
If you are seeking a career where you can truly make a difference, using innovative science and technology to reimagine medicine to improve and extend people’s lives, then look no further.
DOCS is hiring a Global Trial Leader to become part of this rapidly growing team.
If you are a senior Project Manager anywhere in either Netherland or Belgium willing to work home based or office based and open for a new challenges, we would like to hear from you!


Responsibilities:

• Prepares high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
• Escalates corrective and preventive actions (CAPA) to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply.
• Contributes to patient understanding of protocol and patient safety by contributing to the revie of country specific informed consent in accordance with procedural document/templates. This includes creating, reviewing and managing site specific informed consent forms in accordance SOPs, other procedural documents and applicable regulations.



Requirements:

• 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Excellent decision-making and strong financial management skills.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
• Previous line management experience is a plus, but not required. Flexibility and ability to manage study teams in a virtual environment

What is offered:
•A challenging GTL role in an international Pharmaceutical company
•You will enjoy highly competitive compensation and a car allowance
•Largely Home Office Based
•Friendly work atmosphere in a great team
•Contribution to pension scheme
•Travel time = work time

Why this role is right for you:
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV via www.docsglobal.com or iris.brouwer@docsglobal.com. We are looking forward to your application.

#PMjob