Docs Global (Continental Europe)

Local Study Manager / Early Development (m/f)

Location
Germany
Salary
Competitive
Posted
07 Jan 2021
Closes
21 Jan 2021
Ref
23091
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry in Germany. We are looking for interested Study Managers, who like to work in Early Development and want to become a part of this family, adding to the success story.

Roles & Responsibilities of the position:

The Clinical Study Manager will be responsible for managing local clinical studies including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. This role is the primary point of contact at country level for assigned studies in Early Development.

Key Responsibilities:

• Work with regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan.
• Responsibility for site feasibility assessment and implementation of any local criteria for site selection.
• Contribution of input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level.
• Lead of local project planning activities to meet recruitment targets. Including but not limited to development of local trial specific procedures and tools, recruitment planning, contingency and risk management and budget forecasting.
• Monitoring of country progress and initiation of corrective and preventive actions when the trial deviates from plans and communication of study progress and issues to study management teams.
• Review and approval of Monitoring Visit Reports submitted by CRA. Identification of issues and/or trends across a trial project and escalation of deviation issues to the Global Trial Manager as needed.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Active contribution to process improvement; training and mentoring of Clinical Trial Administrators, CRA's and other Study Managers.

Job Requirements:

• Degree in Life Sciences
• Minimum of 2 years of solid clinical project management experience
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements
• Early Development (Phase I and IIa) and Oncology experience highly preferred
• Solid communication and computer skills
• Proficiency in speaking and writing German and English
• Flexible mindset and ability to work at a fast pace within small exploratory study teams
• Ability to work on multiple trials in parallel in different indications

What is offered:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
• Location: Office based, Düsseldorf area. Home Office options can be discussed, but the suitable candidate must be able to commute to the Office every week.
• Permanent employment contract
• Great work atmosphere
• Contribution to pension scheme

To apply:
Would you like to know more? Please submit your CV to anja.potrafke@docsglobal.com or apply directly via www.docsglobal.com. We are looking forward to getting to know you.

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