ARTO
ARTO is partnered with an exciting, well-established cardiovascular focused biotech located in Paris, France
We are helping them source a Head of Clinical Operations to join their growing team and manage their ongoing clinical trials.
Role Overview:
In the capacity of Head of Clinical Operations, you will assume a pivotal position, guiding and supervising the implementation of our clinical trials. Your responsibilities encompass devising and executing strategies to ensure seamless planning, execution, and administration of clinical trials while adhering to regulatory norms. Your direct reporting line to the Chief Medical Officer involves collaborative efforts with cross-functional teams, aiming to drive operational excellence, champion patient well-being, and contribute to the progression of medical knowledge.
Principal Duties:
- Offer strategic leadership and guidance to the Clinical Operations team, fostering a culture characterized by cooperation, ingenuity, and accountability.
- Formulate and execute comprehensive plans for clinical trials, encompassing study schedules, financial plans, and allocation of resources.
- Supervise site selection, feasibility evaluations, and vendor management to assure effective trial execution.
- Forge close collaboration with Medical, Regulatory, and Data Management units to ensure smooth communication and integration of clinical trial undertakings.
- Implement strategies to mitigate risks and proactively tackle potential hurdles that may surface during clinical trials.
- Monitor the advancement of trials, the quality of data, and adherence to protocols, taking corrective measures as necessary.
- Guarantee adherence to all pertinent regulatory statutes, industry benchmarks, and ethical considerations.
- Cultivate partnerships with critical stakeholders, such as investigators, Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), and external associates.
Prerequisites:
- Possession of an advanced degree in life sciences, pharmacy, nursing, or a related discipline. MBA qualification is an added advantage.
- Accumulation of 8+ years of progressive involvement in clinical operations
- Demonstrated accomplishments in steering and managing cross-functional teams within a matrix organizational structure.
- Profound comprehension of global regulatory requisites and ICH-GCP (International Council for Harmonisation – Good Clinical Practice) guidelines.
- A proven history of competently managing multiple concurrent clinical trials.
- Proficiency in communication, negotiation, and effective problem-solving.
- Display of robust leadership competencies, underscored by a dedication to mentoring and fostering team growth.
- Ability to readily adapt to a fast-paced, dynamic work milieu.
- Proficiency in pertinent software and tools for managing clinical trials.
