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Clinical Operations Manager (m/w/d), Single Sponsor

IQVIA Holdings Inc.

Frankfurt/Main, Hesse, Germany

We currently have an exciting opportunity as to work in a sponsor dedicated setting with one key client home-based throughout Germany.

In our Clinical Functional Service Partnership team, we work in a close partnership with our key customers to deliver a comprehensive clinical trial management. Within this role, you will manage a team of CRAs/SrCRAs and maybe other roles like CTAs in Germany, be involved in interesting clinical trial projects of one single pharma client and establish to collaboration with the sponsor.

While projects vary, your typical responsibilities might include:

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 employees, and addressing employee relations issues and resolving problems.
Participate in the selection 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 to clinical studies based on their experience and training.
Conduct monthly review and analysis of assigned projects, including review of revenue recognition, project performance variances, contract opportunities and ad-hoc financial analysis as required
Monitor project and customer activity against contract terms to ensure compliance from operational teams and the customer
Co-ordinate with Project Finance and Global Finance as appropriate to implement process improvements
Review forecasting requirements from customer and completion of month end activities and provide global variance explanations to forecast
Defend financial performance at the Finance review calls; proactively participate in discussions to identify, communicate and address financial issues
Support in Business Review deliverables (Supply vs Demand, Volatility reporting)
Meet Global Finance reporting needs (forecasting, anticipated revenue, variance analysis, ad-hoc requests)
Attend Operational Reviews as needed; share finance results and key messages
Work closely to ensure timely invoice payment
Involvement/Leading initiatives and workstreams to investigate and implement improvements to processes
Act as key point of contact for customer counterpart(s)

You should have:

Bachelor’s or higher-level degree in life science
6 years clinical research experience, preferably including 3 years’ experience in a leadership capacity. Equivalent combination of education, training and experience.
Experience in a CRO or Pharma company, in a project management related role
Fluent languages skills in German 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
Effective communication, organizational, interpersonal, teamwork and leadership skills
Ability to independently coordinate and manage new processes and to effectively prioritize tasks
Positive attitude and ability to interact with all levels of staff and ability to lead and motivate teams
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Flexibility to travel and driving license