Location: Barcelona (Spain)
Contract: Permanent
Sector: Pharmaceutical and biopharmaceutical
Vacancies: 1
Work modality: Hybrid
Job description
The Clinical Project Manager is responsible for the coordination, management, and oversight of clinical research projects (studies and clinical trials) as well as for ensuring that those are completed within the defined timelines, budget and in agreement with the set quality standards and regulations. Based on the level of expertise, the Clinical Project Manager is mainly allocated as primary responsible of low complexity clinical trials/studies (ie. Bioequivalence studies, RWE studies).
Responsibilities
- Ensure that clinical trial/study is properly resourced, managed and executed, within budget, timelines and in compliance with the QMS, regulations and ICH GCP.
- Develop and manage project plans, including defining scope, objectives, and deliverables in collaboration with internal stakeholders following internal Quality Management System procedures.
- Participation in the multi-disciplinary Scientific & Strategic Project team as the responsible of the project clinical development/operations activities • Prepare and/or review and approve essential study documents (ie. Study Protocol and Patient Information sheet, CRF, Clinical Study Report, publications etc.) and other study related documents.
- Management of internal clinical activities and supervise the activities of contract research organizations by reviewing key study performance/ quality and lead risk mitigation activities to ensure the timely delivery of study results and reports that comply with the applicable quality requirements and escalate areas of concern to Clinical Operations Head and Quality Assurance Department as appropriate.
- Clinical Trial main budget control responsible. Supported by the Clinical Operations Head, negotiate contracts and agreements with vendors, sites, and CROs and ensure proper project financial and invoicing status.
- In conjunction with the Clinical Operations Head, evaluation and selection of vendors involved in managed projects.
- Prepare for and manage clinical study audits and inspections conducted by regulatory authorities and internal/external quality assurance teams. Ensure all project documentation, including Trial Master File (TMF), site files, and monitoring reports, are always audit-ready.
- Responsible of clinical trials operational excellence ensuring Risk Based approach is defined in all operational activities.
- Provide regular updates to management for all projects, including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones.
- Build relationships with investigators, clinical trial sites, and other external partners.
Why Ferrer?
- Make a positive impact in society
- Participate in volunteering activities
- Grow in a culture of trust, responsibility, and constructive feedback
- Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
- Make a real difference to the team and to yourself
- Take advantage of opportunities for development & learning
- Discover a range of benefits to support your physical, emotional and financial wellbeing
- Customize your remuneration and benefit
Requirements
What you’ll need to succeed
You will rock at this company if you are a person with empathy, humility, curiosity and optimism.
You will rock at this role if you match with:
- Degree in Science (biological or health science discipline)
- Some Clinical Research and/or Project Management Experience (such as clinical monitoring experience)
- GCP certificate
- Good level of understanding of clinical project management.
- Interpersonal skills with ability to relate to both internal and external stakeholders.
- Communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
- Strategical thinking: ability to seek and understand different perspectives, developing alternative solutions and valuing options suggested by other within the team.
- Ability to work in cross functional teams
- Able to efficiently manage all tasks required during a study, be able to track multiple items.
If this great challenge matches your profile, then we are waiting for you!
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.
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