20 publicaciones de empleo destacadas de non financial risk en barcelona, ct (¡Están contratando!)

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- De 225.500 € a 418.600 € al año
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Dow Jones —Barcelona, Barcelona provincia
- De 75.000 € a 85.000 € al año
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5d
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Dow Jones —Barcelona, Barcelona provincia
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Digital Risk & Vulnerability Management Specialist (m/f/d)
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13d

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Global Study Associate Director - Single Sponsor dedicated

IQVIA -
Barcelona, Barcelona provincia

Solicitar ahora

Detalles del empleo

Jornada completa
De 225.500 € a 418.600 € al año
Hace 4 días

Beneficios

Teletrabajo opcional

Cualificaciones

Investigación clínica
Investigación
Project management
Grado
Gestión de conflictos
Liderazgo

Descripción completa del empleo

Barcelona, Spain | Full time | Home-based | R1566212

The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team and/or study oversight team in accordance with the study team operating model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. guidelines) and in line with values and behaviours.

Essential Functions

Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Accountable for ensuring that information in all systems utilized at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations
Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
Work on non-drug project work such as being a Study Management representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manage
May act as Subject Matter Expert for a particular process or system within Study Management.

Qualifications

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research

5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience
Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
Demonstrated solid project management skills and knowledge of relevant tools
Strong, demonstrated abilities/skills in team leadership
Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills
Excellent communication and interpersonal skills
Strong strategic and critical thinking abilities
Strong organizational and problem-solving skills
Ability to manage competing priorities

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 225.500,00 zł - 418.600,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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