Empleos actuales relacionados con Avp Head of Region, Clinical Trial Operations, Eea - Madrid - MSD
-
Head of Clinical Operations
hace 2 semanas
Madrid, España Barrington James A tiempo completoJob Title: Head of Clinical OperationsLocation: SpainReports To: Chief Operating Officer (COO) / Chief Executive Officer (CEO)About Us:Our partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. With...
-
Head of Clinical Operations
hace 2 semanas
Madrid, España Barrington James A tiempo completoJob Title Head of Clinical Operations Location Spain Reports To Chief Operating Officer (COO) / Chief Executive Officer (CEO) About Us Our partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. With...
-
Head of Clinical Operations
hace 2 semanas
Madrid, España Barrington James A tiempo completoJob TitleHead of Clinical OperationsLocationSpainReports ToChief Operating Officer (COO) / Chief Executive Officer (CEO)About UsOur partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. With our...
-
Head of Clinical Operations
hace 2 días
Madrid, España Barrington James A tiempo completoJob Title¿Quiere enviar su solicitud? Lea toda la información sobre este puesto a continuación y luego pulse el botón de solicitar.Head of Clinical OperationsLocationSpainReports ToChief Operating Officer (COO) / Chief Executive Officer (CEO)About UsOur partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to...
-
Head of Clinical Operations
hace 2 semanas
Madrid, España Barrington James A tiempo completoJob Title:Head of Clinical Operations Location:Spain Reports To:Chief Operating Officer (COO) / Chief Executive Officer (CEO) About Us: Our partner is an innovative and rapidly growing Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. With...
-
Clinical Trial Manager
hace 3 semanas
Madrid, España Advanced Clinical A tiempo completoClinical Trial Manager – Spain | Advanced Clinical (FSP Model)Oncology focusedAdvanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience.Responsibilities...
-
Junior Clinical Trial Manager
hace 2 semanas
madrid, España Advanced Clinical A tiempo completoClinical Trial Manager – Spain | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience. Preparing key...
-
Regional Head of Clinical Operations, Southern and
hace 2 semanas
Madrid, España Bristol-Myers Squibb A tiempo completo**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Clinical Trial Manager
hace 2 días
Madrid, España Exeltis A tiempo completoIn a few wordsPosition: Clinical Trial ManagerLocation: MadridWant to know more? #Exeltis is a leader in the field of ·#Women'sHealth. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000...
-
Executive Director, Clinical Trial Operations
hace 4 días
Madrid, España MSD A tiempo completoExecutive Director, Clinical Trial Operations The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (GCTO) country operations. Adherence to GCP, local and global policies and procedures to conduct high-quality,...
Avp Head of Region, Clinical Trial Operations, Eea
hace 2 semanas
Associate Vice President, Head of Region Clinical Trials, EEA
The Regional Head manages all aspects of clinical trial operations in the region and reports to the Global Head of Global Clinical Trial Operations (GCTO) Regions. This position is responsible for execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and Clinical Research Organization (CRO) run studies. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is responsible for trial quality and audit responses and completion of Corrective and Preventive Action (CAPAs). The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the region, sub-region/clusters and individual countries. The position has multiple touch points with GCTO and staff in the US Research headquarters, or in the Global Clinical Development (GCD) regional office. Additionally, there are important interactions with, _inter alia_, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Global Human Health (GHH)/Value and Implementation (V&I). The Regional Head represents the GCTO organization both internally and externally within the industry.
**Primary activities/responsibilities**:
- Provide Leadership to the Region. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Adhere to Company standards and the respective goals, initiatives and expectations of our research, clinical development and clinical trials operations organisations. Participate and support the goals and objectives of the GCTO Senior Leadership Team (SLT) or extended Leadership Team (eLT). Speak with “one voice” on agreed strategies.
- Manage Clinical Operations activities and personnel within the Region, Regional Country and Cluster Directors, and their respective staff. Ensure that compliance, quality and timeline objectives are met for all trials executed in the region.
- Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM) and regional Quality Managers, to deliver objectives.
- Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate and appropriate resourcing for the Company’s internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) Senior Leadership to ensure the successful implementation of fully-outsourced clinical trials as needed.
- Work with the Global Trial Optimization group within GCTO and Global Medical Directors as appropriate, in site management and selection decisions. Provide input into protocol design, feasibility, and resource assessments as appropriate.
- Support the development and management of Investigator relationships in conjunction with the research organisation’s Therapy Areas, Global Clinical Development and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
- Represent GCTO and the Regions on strategic initiatives at all levels of the organization. Provide leadership to the GCTO organization as a member of the extended GCTO Senior Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and R&D objectives. Set clear performance standards and holds self and organization accountable for achieving results. Embrace GCTO metrics and performance standards (KPI’s)
- Responsible for ensuring appropriate scientific and operational training for staff members.
**Reports to**
Global Head GCTO Regions
**Extent of Travel**
Up to 50%
**Qualifications,** **Skills**
**& Experience**
- An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS,) is preferred or, at minimum, a Master’s Degree in a life science combined with a proven track record of contribution to and delivery of clinical trials. Business and financial management skills are an added advantage (e.g. MBA)
- 10-15 years of experience in clinical operations, preferably in Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation
- Strong Leadership skills that w
