Manager Clinical Operations, Single Sponsor
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Job Description
Manager Clinical Operations overseeing CRAs and supporting clinical trial projects in partnership with a pharmaceutical client in Germany or Switzerland. Flexible and remote work options available.
Responsibilities:
- Manage staff in accordance with organization’s policies and applicable regulations
- Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems
- Participate in the selection process for hiring new employees by conducting candidate review and participating in the interviewing process
- Ensure that new employees are properly onboarded and trained
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities
- Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable
- Participate in the allocation of resources to clinical research projects by assigning staff based on their experience and training
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
- Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management
- May support experienced Managers with conducting review and analysis of assigned projects, including review of revenue recognition, project performance variances, contract opportunities and ad-hoc financial analysis as required
- May support with reviewing forecasting requirements from customer and completion of month end activities and providing global variance explanations to forecast
- May support with initiatives and workstreams to investigate and implement improvements to processes
- Support the collaboration with customer counterpart(s).
Requirements:
- Bachelor’s or higher-level degree in life science
- At least 6 years clinical research experience, including CRA experience
- Experience in a line management role, alternatively a mandatory experience in a line management secondment for at least 6 months
- Fluent languages skills in German on at least C1 level and good command of English
- Full knowledge of drug development process
- Full knowledge of applicable regulatory requirements, like ICH-GCP
- Strong knowledge of financial management and resourcing
- Strong knowledge of Microsoft Office applications
- Ability to independently coordinate and manage new processes and to effectively prioritize tasks
- Flexibility to business travel and driving license.
Benefits:
- Home-office and flexible working schedules
- Attractive compensation and benefits package including e.g. pension, accident insurance and more.
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