Ref #: 28648

Employment type: Permanent - Full-Time

Location: Germany, home based

Posted: 23-Apr-2021

Description

Summary:

DOCS is working in partnership with a highly prestigious organization with one of the most robust clinical study pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry. We are looking for interested Global Clinical Trial Managers who want to become a part of this family and add to the success story.



Roles & Responsibilities of the position:

The Global Clinical Trial Manager provides global, regional or complex local management of
clinical trial data generating activities in a country or countries. Responsibilities include operational oversight of assigned project(s) for end to end project management including start-up, execution, close-out, analysis and reporting.



Key Responsibilities:

- 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 enrolment will be met across the allocated countries.
- 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 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 to support the study and may submit requests for vendor services and support vendor selection.
- Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
- May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.


Job Requirements:

• Bachelor’s degree or equivalent required, preferably in Life Sciences.
• Strong clinical trials background of 8 or more years of clinical study management experience in the pharmaceutical industry or CRO.
• Hands on CRO management, budget management and cross functional management experience.
• Excellent communication skills.
• Excellent decision-making and strong financial management skills.
• Flexibility and ability to manage study teams in a virtual environment.



What is offered:

• Work within one of the most successful global pharmaceutical companies of today
• 100% Home Based
• Permanent contract
• Great work atmosphere
• Interesting pharmaceutical products and indications
• Contribution to pension scheme


To apply:
Would you like to know more? Please submit your CV to timo.kindermann@docsglobal.com or via our homepage www.ICONplc.com/FSP. We are looking forward to getting to know you.
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