Ref #: 29809

Employment type: Permanent - Full-Time

Location: Home Based in Deutschland

Description

DOCS is partnering with one of the most successful global pharmaceutical companies to support them in developing new drugs in critical areas to increase health and quality of live all over the world.


Responsibilities:


The responsibilities include but are not limited to:

Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, codes of Good • Clinical Practice (GCP), local regulatory requirements, etc.
• Complies with relevant training requirements.
• Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures 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. 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 MAO 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.
• 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 review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations


Education & Experience

• Life Science degree or equivalent
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Ample program managing experience in the clinical field.
• Attention to detail, organizational skills, time management & prioritization, proactive personality
• Relationship management & influencing skills
• Proficiency in English and German. French is a plus.
• Good working knowledge of common software packages
• Flexibility and Team skills


What is offered:

• 100% Home Office
• Permanent contract
• Friendly work atmosphere in a great team
• Compensatory time-off
• Contribution to pension scheme



Why this vacancy 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 a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested?

Please submit your CV to roger.bravomendez@docsglobal.com or apply via www.docsglobal.com. We are looking forward to your application !