Project Director, Clinical Operations

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative \“one-team\“ culture. We are looking for a dynamic person to join our in-house team as a Project Director, Clinical Operations on a permanent basis. This is a remote position, in Germany.

The Project Director, Clinical Operations is responsible for the accountability of the assigned clinical projects in order to ensure that clinical projects are delivered on time, within budget and with the required quality standards. Applicants must have a strong background with Oncology and/or Respiratory trials.

Main Job Tasks and Responsibilities:

1. Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
2. Manage the projects at a global level and ensure consistent and continuous focus to Client\’s specifications and satisfaction.
3. Meet and exceed the project\’s deliverables: timelines, budget and quality.
4. Set project plans, monitor the adherence to the plans, proactively address with Project Leader/Project Director and his/her team any risk of variations.
5. Plan and manage the Project Boards for the assigned projects and agree with the Global Head on the project needs.
6. Responsible for the identification, resolution and escalation of any issues.
7. Achieve the Project KPIs, understand performance issues, share best practices and lessons learnt.
8. Define, plan and manage internal and external communications on the assigned projects planning and status.
9. Serve as a source of scientific and therapeutical expertise.
10. Give scientific and operational input to proposal development and contribute to the preparation of the strategic documents and bid defense meetings.
11. May act as Program Director for existing and potential new projects.
12. May participate in Monitor\’s and Investigator\’s Meeting.
13. Give input to the Clinical Research Operations Department Senior Director for periodic performance assessment on the basis of projects management experience.
14. Monitor and enforce compliance with ClinChoice systems, processes, policies and all applicable regulations.
15. Participate in review/design of processes and SOPs providing input based on projects management experience.
16. Maintain relationships with the Sponsors.

Education, Experience and Skills

1. University Degree in scientific and/or medical disciplines.
2. Eight years (at least) of Clinical Research experience in the CRO/Pharmaceutical industry and after gaining excellent knowledge in developing work organization models.
3. Strong knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
4. Fluent in English and local language(s).
5. Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
6. Willingness to travel.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Clinical Research Department Director, Clinical Research Director, Clinical Director, Oncology, Respiratory, Bid Defense, CRO, Contract Research Organisation

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