Senior Clinical Team Manager

hace 6 días

Madrid Centro, Madrid, España Importante empresa A tiempo completo

We are a vital link between innovative ideas for new medicines and the people who need them. As a key member of our team at Importante empresa, you will be part of a global organization that is dedicated to improving health. Our collaborative and winning culture is built on a shared purpose: to bend the time and cost curve of delivering life-saving therapies to patients.

Our Project Delivery team is responsible for directing, coordinating, and leading the technical and operational aspects of projects, ensuring the successful completion of clinical trials. The team is therapeutically aligned to respond better to our customer needs. The therapeutic scope includes:

General Medicine, Hematology/Oncology, Infectious and Respiratory Diseases, Cardiovascular/Metabolic/Critical Care, Neuroscience, and Vaccines.

We are currently seeking an experienced Clinical Team Manager to join our team. This exciting role will take you to the next level of your career within Clinical Research. As a Clinical Team Manager, you will combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You will take ownership, anticipate problems, find solutions, and deliver results.

The role involves coordinating all aspects of clinical activities on an international basis, including:

  1. Day-to-day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
  2. Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
  3. Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking, and quality systems
  4. Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick-off meetings
  5. Clinical Resource Management - provide input into preparation of forecast estimates of clinical deliverables, assignments, and identification of additional resource requirements
  6. Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

Qualifications

To be successful in this role, you will need:

  1. Bachelor's degree or licensed certified healthcare training or equivalent combination of education and experience
  2. Previous cross-country CTM/Project Management experience in excess of 2 years, including specific knowledge for General Medicine: Gastrointestinal diseases (NASH, Ulcerative Colitis, Chron's Disease, Constipation, Inflammatory Bowel Disease); Immunology (Lupus, Rheumatoid Arthritis, Gout, Osteoarthritis); Dermatology (Atopic Dermatitis, Psoriasis); Women's health and Genitourinary
  3. Gene therapy experience would be considered an advantage
  4. Clinical research experience in all phases of study life cycle, including start-up, interim, and close-out
  5. Study finance management experience
  6. Ability and willingness to cross-region and in-region travel according to the project needs
  7. Valid Passport and Driving Licence
  8. Be competent in the use of written and oral English language

Knowledge, Skills, and Abilities:

  1. Superior organizational skills
  2. Critical thinking skills
  3. Demonstrated performance management abilities
  4. Excellent judgment and decision-making skills
  5. Highly effective verbal and written communication and presentation skills
  6. Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines

This role is open to all EMEA locations for office or home-based employees. At Importante empresa, we value a work-life balance and offer a flexible working culture. We are committed to developing our employees and providing an award-winning learning and development program. Our benefits package is designed to support the health and well-being of our employees. We are a global organization with a local feel, and our 4i values are: Integrity, Innovation, Intensity, and Involvement.

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