Clinical Operations Manager
hace 3 semanas
Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources._We are looking for applicants interested in a part time assignment of 6 to 8 months._
Essential Functions
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
- May take a lead role in developing long standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
**Qualifications**:
- Bachelor's Degree Life sciences or related field Req
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
- Good regulatory and/or technical writing skills
- Good leadership skills, with ability to motivate, coach and mentor.
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions.
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Clinical Trial Manager
hace 3 días
Madrid, España Al Solutions A tiempo completoClinical Trial Manager - Start-up CRO - Spain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staff!This role is working remotely in Poland. This is a unique...
-
Clinical Trial Manager
hace 3 días
Madrid, España Al Solutions A tiempo completoClinical Trial Manager - Start-up CRO - Spain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staff!This role is working remotely in Poland. This is a unique...
-
Clinical Trial Manager Ii
hace 4 semanas
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager II, Real World & Late phase studies** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and...
-
Sponsor Dedicated Clinical Trial Manager Ii
hace 1 mes
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II / Sr CTM - Home Based in SPAIN** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...
-
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm
hace 4 semanas
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** Experience in the management of global/multi-country studies is required Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...
-
Senior Legal Counsel
hace 1 mes
Madrid, España EastHORN Clinical Services A tiempo completoFounded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award...
-
Medical Operations Manager
hace 4 semanas
Madrid, España Oxford Global Resources A tiempo completo**Medical Operations Manager**: - Location: Madrid, Spain - Contact: Susagna Sastre Magem - Job type: Contract - Industry: Pharmaceutical, Life Sciences, Biotechnology Oxford Global Resources is looking for a Medical Operations Manager in Madrid who will be joining a research-based bio pharmaceutical company that discovers, develops, and commercializes...
-
Clinical Research Manager
hace 1 mes
Madrid, España Johnson & Johnson A tiempo completoGlobal Clinical Operations (GCO) Position Title: CLINICAL RESEARCH MANAGER (Functional Manager II) **Position Summary**: The Clinical Research Manager (FM II) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource...
-
Clinical Manager
hace 3 días
Madrid, España Robert Walters Spain A tiempo completoEn la División de Pharma de Robert Walters buscamos un Clinical Manager para compañia farmaceutica con base en Madrid.Reportando a Direccion Científica, será la persona experta / especialista médico de los productos de la empresa:Funciones:Realizar la puesta en marcha, control y seguimiento de los enayos clínicos en todas sus fases y de los estudios...
-
Clinical Trial Manager
hace 3 días
Madrid, España Precision Medicine Group A tiempo completo.We have current opportunity for an experienced Clinical Trial Manager in Europe! Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...
-
Clinical Trial Manager
hace 24 horas
Madrid, España Medpace, Inc. A tiempo completoJob Summary: Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Spain, particularly in our Madrid office. Clinical Trial Managers with expertise in Cardiovascular/Endocrine/Metabolic are welcome to continue to work in their area of...
-
Medical Operations Manager
hace 4 semanas
Madrid, España Oxford Global Resources A tiempo completoLocation: Madrid, Spain - Contact: Susagna Sastre Magem - Job type: Contract - Industry: Pharmaceutical, Life Sciences, Biotechnology Oxford Global Resources is looking for a Medical Operations Manager in Madrid who will be joining a research-based bio pharmaceutical company that discovers, develops, and commercializes innovative medicines in area of unmet...
-
Office Operations Manager
hace 1 mes
Madrid, España Walters People A tiempo completoAcerca del rol de Office Operations Manager: En esta posición, como Office Operations Manager en un importante Despacho de Abogados ubicado en el centro de Madrid, tu misión principal será gestionar la oficina, coordinar los servicios generales y ser el princpal punto de comunicación para empleados y otras oficinas. **Responsabilidades clave**: -...
-
Project Manager
hace 4 semanas
Madrid, España Page Personnel España A tiempo completoLa persona que se incorpore como Project manager / Operations manager (h/m) deberá cumplir las siguientes funciones: - Estudio de viabilidad técnica y económica de localesControl de las obras realizadas, desviaciones presupuestariasControl presupuestario y de tesorería del productoMantenimiento y control de la seguridadControl y relación con los...
-
Operations Manager
hace 4 semanas
Madrid, España Kudelski Sa A tiempo completoDo you like Sports? Do you like working with cutting-edge technology? Are you methodical and analytical, but still comfortable managing uncertainty? Do you want to work in an international and multi-cultural environment? Come work with us! Location : Madrid, Spain MISSION Nagra Sports is an OTT streaming & monetization platform, that enables Sports...
-
Associate Clinical Quality Manager
hace 3 días
Madrid, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Financial Controller Clinical Diagnostics
hace 4 semanas
Madrid, España Eurofins Spain A tiempo completoDescripción de la empresa The Eurofins Clinical Division, since its creation in 1988, has worked to consolidate itself day by day as a large laboratory for clinical analysis. After 25 years of experience and a proven track record, The company is currently one of the largest laboratories in Spain. We are a national leader in services, information,...
-
Product Manager Clinical Research
hace 4 semanas
Madrid, España Werfenlife Sa. A tiempo completoThis position it's intended for a person with broad skills in the most used and well known biotechnology techniques, as well as knowledge of the market trends and the latest technology updates. Whithin the Life Science department, the individual will contribute in the implementation and growth of specific business lines, specially in the area of Clinical...
-
Operations Manager
hace 1 mes
Madrid, España Nagra DTV A tiempo completoStimulating. Motivating. Challenging. Do you like Sports? Do you like working with cutting-edge technology? Are you methodical and analytical, but still comfortable managing uncertainty? Do you want to work in an international and multi-cultural environment? Come work with us! Location : Madrid, Spain MISSION Nagra Sports is an OTT streaming &...