Sr Clinical Trial Manager
hace 2 semanas
**Description**
**Senior Clinical Trial Manager**
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 customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
- Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
- May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participates and presents in key meetings such as Kick Off Meeting.
- Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
- Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
- Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboa
-
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** **Experience as CTM in the management of global/multiple-countries 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...
-
Local Clinical Trial Manager I. Spain. Sponsor
hace 3 semanas
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager** 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...
-
Barcelona, España Somm Excellence Alliance A tiempo completoThe Vall d´Hebron Institute of Oncology (VHIO) Seeks a “Clinical Trial Coordinator and Project Manager”. Reference: Ref. 74-2023 Application deadline: 17/12/2023 Number of vacancies: 1 Job description: We offer a position in the scientific management department to support the execution of the clinical management of an international academic clinical...
-
Barcelona, España AstraZeneca A tiempo completo**Location: Warsaw (PL), Barcelona (ES) or Cambridge (UK)** The Clinical Transparency & Data Sharing team is within CMO office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities such as the...
-
Barcelona provincia, España Bespoke Recruitment A tiempo completo**Location: Cork, Ireland** - Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents - Directly communicate with sites to facilitate start-up and continue active collaboration with sites throughout maintenance and close-out. - Recognize, discuss, and...
-
Manager Clinical Operations
Encontrado en: beBee S ES - hace 4 semanas
Barcelona, España ICON Clinical Research A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Global Clinical Project Manager - Home Based in Spain** Previous experience in global trial management and vendors management is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and...
-
Senior Clinical Project Manager
hace 3 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Senior Project Manager** 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...
-
Sr Clinical Research Scientist
hace 1 día
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Senior Clinical Research Scientist** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...
-
Sso Clinical Project Manager
hace 3 días
Barcelona, España Novartis A tiempo completo100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...
-
Trial Master File Lead
hace 2 días
Barcelona, España TFS HealthScience A tiempo completoOverview: TFS HealthScience is excited to be expanding our **TMF Operations and Systems Business **team and we are looking for an experienced, highly motivated **Trial Master File Lead (TMF Lead) **who shares our vision of providing clinical research excellence. Our **TMF Operations and Systems Business **team is a highly experienced international group of...
-
Director, Clinical Trial Excellence
hace 1 día
Barcelona, España AstraZeneca A tiempo completoExperience of working in a CRO would be advantageous.Track record of delivering process improvements in a complex matrix team environment. Strong interpersonal, and written/verbal communication skills.Highly conversant and knowledgeable of relevant existing and new/emerging regulations and guidances. Detailed understanding of GCP regulations as applied to...
-
Clinical Research Medical Advisor
hace 2 semanas
Barcelona, España Novartis A tiempo completoAbout the role: Clinical Research Medical Advisor - Oncology, Spain or UK, #LI-Remote.The Clinical Research Medical Advisor is a Global Clinical Development role with medical responsibility for the clinical trial process. It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations & strategy.Based...
-
Global Study Manager, Oncology R&D, Early Oncology Clinical
hace 2 semanas
Barcelona, España Astrazeneca Gmbh A tiempo completoLocation: Barcelona, Spain (on-site) / Able to be office based (3 days per week) in the Barcelona office from day 1. For candidates living in other locations requiring relocation, candidate should be able to relocate and start in the AZ role within 2 months once offer is accepted. AZ will not provide relocation package for this role. The Global Study Manager...
-
Etmf Project Manager
hace 1 semana
Barcelona, España Transperfect A tiempo completoeTMF Project Manager - Trial Interactive page is loaded eTMF Project Manager - Trial Interactive Apply locations Spain-Barcelona time type Full time posted on Posted 30+ Days Ago job requisition id R2019-7318 TransPerfect Is More Than Just a Job… Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that....
-
Clinical Research Medical Advisor
hace 2 semanas
Barcelona, España Novartis A tiempo completoAbout the role: Clinical Research Medical Advisor - Haemato-Oncology, Spain, #LI-Remote.The Clinical Research Medical Advisor is a Global Clinical Development role with medical responsibility for the clinical trial process. It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations & strategy.Based...
-
Associate Manager, Clinical Trials Regulatory Management
Encontrado en: Talent ES C2 - hace 1 día
Barcelona, España IQVIA A tiempo completoPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
(Ik004) Sr Technical Manager
hace 3 semanas
Barcelona, España Cbre A tiempo completoReportando jerárquicamente al Manager y funcionalmente al Head of Technical Management Department asumirá las siguientes funciones:técnica con el cliente y ocupantes.de equipo técnico a su cargo.de las directrices marcadas por los servicios técnicos centrales de CBRE e implantación de los proyectos correspondientes.y seguimiento de OPEX, CAPEX y Plan...
-
Clinical Study Manager
hace 1 día
Barcelona, España Veranex, Inc. A tiempo completoVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Clinical Project Manager
hace 2 días
Barcelona, España TFS A tiempo completoTFS HealthScience is excited to be expanding our SRSteam and we are looking for an experienced, highly motivated Clinical Project Manager / Clinical Trial Manager who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert. We are a leading global...
