Senior Clinical Study Manager - Barcelona, España - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Sr

Clinical Study Manager:

Location:
Europe

Thermo Fisher Scientific Inc

(NYSE:

TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

The mission of the Clinical Affairs group within the Medical and Scientific Affairs is to create customer value for ImmunoDiagnostic Division (IDD) by providing clinical evidence for product pre-launch and post-launch across the portfolio.

IDD develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases.

With 1,900 employees worldwide working with these products, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.

The role, Sr Clinical Study Manager, can be based in Europe - remote, and will be reporting to the Global Director Clinical Affairs.

The job

Own IDD Clinical Affairs planning, execution, and reporting.
Develop timely and efficient clinical strategies to support product claims.
Liaise with Regulatory Affairs organization to complete prioritized product registration plans in selected geographical areas.
Liaise with R&D organization to align on product specifications to be fulfilled and patient cohorts to be targeted.
Liaise with Commercial Operations organizations to ensure desired products are available for sales on the territory.
Liaise with Marketing organization to leverage on key customers and KOLs within clinical trials and support building sales supporting arguments on top of registrationrelated claims.

Key Responsibilities

Lead crossfunctional, highcomplex and business critical clinical projects.
Hold accountability and responsibility of all operational and safety deliverables of assigned company sponsored studies.
Develop relevant clinical strategies and plans.
Ensure clinical research programs are crafted and conducted in accordance with company standards operating policies & procedures (SOPs), Good Clinical Practices (GCP), ISO20916:2019, In-Vitro Diagnostics Device Regulation (IVDR) and FDA regulation.
Review clinical evaluation plans and reports for scientific rigor.
Identify project risks and develop & implement mitigation plans.
Coordinate, plan, and lead crossfunctional, highly sophisticated, and businesscritical projects, with a focus on development, registration, and commercialization of ImmunoDiagnostics products.
Guaranty Audit and Inspection preparedness of all assigned projects.
Be responsible for corrective action plans at individual sites and across trial.
Report project progress to governance boards and raise issues to IDD management.
Provide decision support and recommendations for critical decisions to IDD management.
Help identify and drive assigned department goals.

Knowledge, Skill, and Ability

Demonstrate Leadership to develop, empower and guide personnel to meet objectives.
Excellent interpersonal written and verbal skills to communicate effectively across crossfunctional departments and crosssites.
Proficient knowledge of medical terminology, clinical trial design and statistics both for product registration and postmarket followup.
Proven detailed knowledge of guidelines, systems for clinical trial management and international regulations and practices (knowledge of CE IVDR required and IVD FDA/CFDA strong asset).
Expertise with ISO20916:2019 required.
Knowledge of immunology, allergy and/or autoimmunity strongly preferred.
Ability to develop and implement solutions to address identified problems.
Excellent study management, interpersonal and time management skills.
Willingness and ability to travel oversea for up to 3050% of time.
Ability to work in a complementary team and sophisticated environment and adapt to changing priorities.
Ability to provide clear directions and mentorship to others.
Vendor selection and management experience
Desire to use experience to build innovative infrastructure and "standard processes".
Knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and skill in using Microsoft Office suite.

Education

Bachelor's degree in biological sciences, nursing or related medical/scientific field or equivalent work experience.
5 years+ experience preferred in global clinical research management experience in medical devices with a minimum specifically in invitro diagnostics area.
Advanced written and spoken English and additional European language preferred.

Thermo Fisher Scientific is