Clinical Operation Manager Regulatory And Start Up

4 giorni fa

Milano, Italia Novasyte A tempo pieno

Job Overview
Our teams are growing
- We are looking for a Clinical Operation Manager | Regulatory and Start Up Manager to work fully dedicated to one of our biggest sponsor.
- This person will 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.
- 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.
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- 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
- What we offer:
- We offer genuine career development opportunities for those who want to grow as part of the organisation.
- The chance to work on cutting edge medicines right at the forefront of new medicines development.
- IQVIA has access to significant data pools allowing better site selection and recruitment.
This helps drive performance of sites making the CRA role more efficient and discussions at site more productive.
Next generation clinical development
- Flexible conditions and an attractive remuneration package.- We know that meaningful results require not only the right approach but also the right people.
Regardless of your role, we invite you to reimagine healthcare with us.
You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career

  • Clinical Operation Manager Regulatory and Start Up

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Job Overview Our teams are growing! - We are looking for a Clinical Operation Manager | Regulatory and Start Up Manager to work fully dedicated to one of our biggest sponsor. - This person will direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including...

  • Regulatory & Start-up Specialist (Homebased)

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    IQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products. IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...

  • Regulatory & Start-Up Specialist (Homebased)

    2 settimane fa

    Milano, Italia Novasyte A tempo pieno

    IQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.IQVIA MedTech's focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...

  • Clinical Start Up Manager Milan

    6 mesi fa

    Milano, Italia Resourcing Life Science A tempo pieno

    Company Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally.They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access.They are currently seeking a Clinical Start up Manager office based in Milan.Job Overview Leading cross-functional project...

  • Study Start Up Manager

    6 giorni fa

    Milano, Italia Ergomed A tempo pieno

    Company Description Ergomed is a rapidly growing global clinical research company. We perform clinical trials for rare and complex diseases. Ergomed Plc is a public company on the London stock exchange. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent...

  • Study Start Up Manager

    4 giorni fa

    Milano, Italia Ergomed A tempo pieno

    Company DescriptionErgomed is a rapidly growing global clinical research company.We perform clinical trials for rare and complex diseases.Ergomed Plc is a public company on the London stock exchange.The company boasted 40% growth in its revenues in its last report.This success is due to the hard work of our highly skilled employees and our subsequent...

  • Study Start-up Specialist

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Study Start Up Specialist, IQVIA Biotech - Italy - Homebased - IQVIA Biotech is looking for an experienced Clinical Study Start-up professional to join our Study Start-Up Unit. - The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document...

  • Regulatory and Start Up Specialist

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. _Hungarian and English Fluent._ Essential Functions -...

  • Regulatory & Start Up Specialist 1

    1 settimana fa

    Milano, Italia IQVIA A tempo pieno

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...

  • Study Start-Up Specialist

    2 settimane fa

    Milano, Italia Novasyte A tempo pieno

    Study Start Up Specialist, IQVIA Biotech- Italy - Homebased- IQVIA Biotech is looking for an experienced Clinical Study Start-up professional to join our Study Start-Up Unit.- The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document...

  • Regulatory and Start Up Specialist

    28 minuti fa

    Milano, Italia IQVIA A tempo pieno

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...

  • (Study Start-up) Initiation Clinical Research

    1 settimana fa

    Milano, Italia Parexel A tempo pieno

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

  • Regulatory And Start Up Specialist

    5 giorni fa

    Milano, Italia Novasyte A tempo pieno

    Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.May also include maintenance activities._Hungarian and English Fluent._Essential Functions- Under...

  • Regulatory and Start Up Specialist

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Italian and English Fluent. Essential Functions - Under...

  • Regulatory & Start Up Specialist 1

    7 giorni fa

    Milano, Italia Iqvia A tempo pieno

    Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.May also include maintenance activities.Essential Functions- Under general supervision, serve as...

  • (Study Start-Up) Initiation Clinical Research

    7 giorni fa

    Milano, Italia Parexel A tempo pieno

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart.They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.As a CRA at...

  • Regulatory And Start Up Specialist

    5 giorni fa

    Milano, Italia Novasyte A tempo pieno

    Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.May also include maintenance activities.Italian and English Fluent.Essential Functions- Under general...

  • Oncology Study Start-up Manager

    1 mese fa

    Milano, Italia AstraZeneca A tempo pieno

    At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. Welcome to MIND (Milan), one of over 400 sites here at AstraZeneca. The site provides a collaborative environment...

  • Associate Local Start Up Manager

    6 giorni fa

    Milano, Italia Labcorp A tempo pieno

    The Associate Local Start Up Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments...

  • Start Up

    1 mese fa

    Milano, Italia Mil Fortrea Clinical Development Ltd Filiale Italiana A tempo pieno

    As 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.Conducting operations in...