Clinical Studies Manager
D-ploy (Czech Republic) s.r.o., Czech Republic

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.

We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity and contribute to the organization’s success and value.

We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us!

Tasks and Responsibilities

• Responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase)
• Agree with customer team and Line Functions on realistic project and study timelines
• Lead and manage a multidisciplinary cross functional Clinical Trial Team = medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.
• Responsible for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
• In collaboration with other departments to support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated colleagues
• responsible for review of all site visit related reports and quality control of monitoring activities in timely manner
• Coordinate the data analysis and interpretation for first interpretable results (where applicable) with Customer Medical Representative
• Responsible for Clinical Study Report, either directly contributing to or managing the report writing, or by liaising with the team or customer medical writing/narrative group to ensure report is completed according to current requirements
• Work with other departments to identify potential issues and implement actions to resolve them.
• Where applicable oversee the work of assigned Clinical Operations Specialists, ensuring clear delegation /assignment of duties are documented
• Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives.
• Acting as a mentor, including training and onboarding of new associates

Requirements

• Relevant educational background in life sciences/healthcare would be ideal
• 6+ Clinical Operations experience with managerial experience in planning, executing, reporting, and publishing clinical studies in a pharmaceutical company or a research organization.
• Good project management skills
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
• Willingness to act accountably in project/study management.
• Ability to resolve issues with minimal supervision and understand when to escalate
• Good communication skills with demonstrated presentation and diplomacy skills.
• Fluent English (spoken amp; written)
• Candidates must declare Criminal record extract not older than three months

Benefits

• Broad range of activities, tasks, and projects
• Flexible working conditions
• Minimum 5 weeks of vacation
• Paid sick days
• Meal vouchers
• Vouchers (B-day voucher, wedding, and new born surprise)
• Contributions to wellness programs (multisport card)
• Fishing for Friends program our referral program
• Refreshments in the D-ploy office
• Further development and professional advancement
• Friendly and international working environment
• Company-sponsored events
• Competitive salary and various benefits

Job Rewards and Benefits