Senior Clinical Project Manager

hace 7 meses

Madrid, España ClinChoice A tiempo completo

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 Senior Clinical Project Manager to join their internal team in Spain. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As Senior Clinical Project Manager you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career

**Main Job Tasks and Responsibilities**:

- Supervise the assigned clinical research projects.
- Coordinate and maintain the planning of the activities for the assigned projects.
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
- Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
- Verify the assigned project activities plan, timelines and the related critical state.
- Manage the budget for the project.
- Share the workload and the performance of the project team with the assigned Clinical Research Department Director.
- Supervise Clinical Research Associate (CRAs) activities, ensuring compliance with ICH-GCP guidelines and applicable laws and regulations.
- Supervise the Clinical Trial Administrators (CTAs) and CRAs in terms of local authorities approval activities.
- Supervise the CTAs in archiving activities.
- Supervise the overall management of the project, including the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
- Assist the Medical Monitor in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs).
- Arrange and collaborate with the assigned Clinical Research Department Director, in identifying project specific trainings of the project team and in delivering them.
- Participate in Monitor's and Investigator's Meetings.
- Organise and/or take part in the periodic project update meetings.
- Provide project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director.
- Inform Project Director/Leader and the Clinical Department Director about any issues that can jeopardise the business relationship with the Sponsor.
- Perform, if necessary, co-monitoring visits for the assigned clinical projects.
- Carry out the monitoring of the sites for the assigned projects, when requested and if applicable.
- May tutor Project Coordinators/Project Managers.
- May act as Feasibility Associate after appropriate and documented training.
- Maintain relations with the Sponsor.
- Prepare the SOPs relating to the clinical research activities in collaboration with the Quality System Unit.
- Collaborate in complying and enforcing Company procedures.

**Education and Experience**:

- University Degree in scientific, medical, or paramedical disciplines.
- Minimum of eight years of clinical research experience in Project Management in the CRO/Pharmaceutical industry.
- Excellent knowledge of clinical trial operations, GCP-ICH guidelines and other applicable regulatory requirements.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
- Willingness to travel.

**The Benefits of Working in Spain**:

- Competitive salary
- Health insurance
- Home office allowance
- Meal vouchers
- 23 days of holiday + 2 convenio days
- Excellent work-life balance
- Dedicated Line Manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within ClinChoice, locally and globally
- Employee satisfaction survey - your feedback is important for continuous improvement

**The Application Process**:
**Who will you be working for?**

**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 acc

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