Job description: Overview As a Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Within this program you will thrive within a fast-paced, dynamic study de…

Expected salary:

Location: Canada

Job date: Fri, 06 Oct 2023 02:36:45 GMT

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Job description: Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline bmanner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Qualifications

What do you need to have

Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH- GCP as well as relevant local regulations.
• Excellent project management skill
• Excellent team building and interpersonal skills
• Excellent organisational skills
• Excellent verbal and written communication skills
• Excellent ability to prioritize and handle multiple tasks
• Excellent attention to details
• Excellent knowledge of spoken and writtenEnglish
• Good negotiation skills
• Good ability to learn and to adapt to work with IT systems.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Offre d’emploi
ICON plc est un chef de file mondial en matière de soins de santé intelligents et de recherches cliniques. De la molécule au médicament, nous faisons progresser la recherche clinique en offrant des services externalisés aux entreprises pharmaceutiques, biotechnologiques, et d’équipement médical, ainsi qu’aux organismes gouvernementaux et de santé publique.
En plaçant nos patients au cœur de toutes nos activités, nous contribuons à accélérer le développement de médicaments et de dispositifs qui sauvent des vies et améliorent la qualité de vie.
Nos employé(e)s sont au cœur de notre culture et constituent la force motrice de notre succès. Les employé(e)s d’ICON ont pour mission de réussir et sont animé(e)s d’une passion qui garantit que ce que nous faisons, nous le faisons bien.
Description du poste :
Le/la gestionnaire de l’essai clinique (GEC) est responsable de la réalisation de tous les aspects cliniques de l’étude. Le/la GEC supervise la partie clinique du budget, élabore des plans et des outils de suivi, forme les associés de recherche clinique (ARC), pilote les activités d’inscription et de démarrage de l’étude, passe en revue les rapports de déplacement, met en œuvre des plans d’action correctifs et préventifs, assure la liaison avec le commanditaire, les fournisseurs et les équipes interfonctionnelles, identifie et atténue les risques susceptibles d’avoir un impact sur la prestation clinique, et fournit des rapports et des mesures sur toutes les activités cliniques. Le/la GEC participera également aux réunions avec les promoteurs et les chercheurs, ainsi qu’aux réunions de défense des offres.
Vous aurez besoin de :

• Un baccalauréat en sciences de la santé, en sciences de la vie ou dans un autre domaine d’études pertinent
• 5 ans et plus d’expérience en recherche clinique, requis
• 1 à 2 ans d’expérience comme GEC, fortement préférés
• 2 ans et plus d’expérience en suivi, fortement préférés
• Solide connaissance du processus de développement des médicaments
• Solide connaissance et application pratique des exigences réglementaires pertinentes
• Excellentes compétences en gestion de projet
• Excellentes compétences en leadership et capacités d’influence
• Excellentes compétences en résolution de problèmes
• Excellentes capacités de pensée critique
• Maîtrise de la suite Microsoft Office et des applications de collaboration d’entreprise
• Maîtrise de l’anglais (capacité à lire, écrire, parler), requise
• Déplacement jusqu’à un maximum de 10 %, requis

Chez ICON, notre objectif est de vous offrir une rémunération globale complète et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large éventail de programmes de rémunération variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-être de première qualité, afin de vous soutenir, vous et votre famille, à toutes les étapes de votre carrière, maintenant et à l’avenir.

ICON, y compris ses filiales, est un employeur inclusif qui offre des chances égales et s’engage à offrir un cadre de travail exempt de discrimination et de harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d’une considération égale pour l’emploi, sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap ou le statut d’ancien combattant protégé.

Si, en raison d’un problème de santé ou d’un handicap, vous avez besoin d’un aménagement raisonnable pour toute partie du processus de candidature, ou pour exécuter les fonctions essentielles d’un poste, veuillez nous en informer au moyen du formulaire ci-dessous.

Expected salary:

Location: Canada

Job date: Fri, 10 Nov 2023 04:53:54 GMT

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Job description: Job Description:

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for an experienced Clinical Trial Leader / Senior Clinical Trial Leader

The Clinical Trial Leader (CTL) provides leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. The CTL serves as a proactive member of the core project team, liaising closely with the Project Manager (PM) and other department leaders if /when necessary on all trial-related issues and service delivery. The CTL will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA teams. The CTL may support the management team with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.

This is a full-time, direct hire opportunity for an experienced Trial Leader residing in the US, Canada or Mexico. Ideal candidates should have a combination of SCRA + CTL/CTM or Regulatory/Auditing industry experience providing oversight to Oncology, Infectious Diseases and/or Vaccine (Covid specific) clinical trials.

Location: Remote role for candidates residing in US, Canada, or Mexico

Travel: On rare occasions where travel is needed, may require 10% travel to attend bid defense meetings, company visits, possible audits, etc.

Preferred TA experience: Oncology, Infectious Diseases, Vaccines (Covid specific)

The CTL/ Sr. CTL will be responsible for the following tasks:

• Responsible for coordinating and managing CRA activities across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met, including: • Manages the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM).
• Oversight of critical documentation collection, maintenance and filing.
• Develop the Monitoring Plan and site monitoring templates and tools.
• Provide input into Trial plans and tools (e.g., protocol, Project Plan, Data Management Plan, eCRF Guidelines, TMF Plan, TMF Index, Risk Log, Recruitment Plan & trackers, Site Activation Management Plan, Regulatory and Ethics Submission Plan (RESP), Clinical Trial Agreement & Budget Plan (CTABP), Investigation Product Release Authorisation Plan (IPRAP), Trial Non-Compliance Management Plan, Medical Monitoring Plan, Safety Management Plan, Centralized Monitoring Plan, etc.)
• For trials with separate unblinded monitoring and when assigned unblinded CTL role, develops or assists the PM in the development of CRO Blinding Plan, Unblinding Plan and all necessary tools and templates for the unblinded monitoring and site activities.
• Reviews trial-specific documents upon request (e.g., Protocol, Subject Information Leaflet/Informed Consent Forms, Laboratory Manual, Pharmacy Manual)
• Develops or reviews subject-facing materials such as: Letter for the GP, Subject ID card, instructions for the subjects (if necessary)
• Customizes the annotated Site Visit Reports according to trial specific requirements.
• Selection of investigators and sites; SEV report review and approval.
• Site initiation management; SIV report review and approval
• Monitoring Visit Report (MVR) review, management, resolution and escalation.
• Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as well guiding the CRA team
• Manages successful trial close-out, identifies critical activities to make timely and efficient close-out.
• Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management .
• Coordinates and manages CRA site assignments, site visit schedules and site management activities.
• Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed.
• Conducts project co-monitoring (if required).
• Coaches/mentors CRA team. Provides performance feedback on team members as appropriate • Assists in developing and delivering project-specific training and provides input related to Project Specific Training Matrix.
• Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls.
• Oversees / attends CRA handovers as appropriate.
• Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable.
• May be assigned to temporarily conduct site management and monitoring in case of immediate need and lack of resources.
• Monitors and manages trial materials supplies. Ensures Investigational Product and other trial supplies are shipped to sites.
• Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff.
• Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation.
• Participates in the development of trial newsletters communication.
• Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs.
• Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise.
• Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct.
• Oversees eTMF status.
• Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities
• Contributes to optimization of trial processes to increase efficiency
• Coordinates and provides support for trial related (site) audits & inspections
• Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure
• Ensures project consistency within and across projects by following Allucent / relevant SOPs.
• Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related).
• Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
• Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable.
• Supports PM in the management of trial vendors as required.
• Project contract awareness and oversight; i.e.:

• Forecast and report on the site management units throughout project life cycle
• Identify changes in scope and liaise with the Project Manager
• Manages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS.
• Provides input into proposals when required.
• Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients
• Complete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)
• Other responsibilities as required.

Requirements:

• Based in the United States of America, Canada or Mexico
• A degree in life sciences or nursing qualification preferred, but not required
• A minimum of 5 years clinical research experience (including a combination of SCRA + CTL/CTM, PM or Regulatory/Auditing experience).
• In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials
• Strong therapeutic background
• Possesses experience and knowledge in the CRO industry that will support Allucent’s management of clinical trials Skills
• Strong written and verbal communication skills including good command of English language
• Professional and strong client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence with attention to detail and accuracy
• Leadership and mentoring skills with ability to mentor and train other CRAs in a positive and effective manner
• Excellent team player with team building skills
• Strong organizational skills to be able to manage a full workload across multiple projects.
• Demonstrates flexibility for creating solutions and process improvement
• Analytical, financial and problem resolution skills
• Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required
• Ability to successfully manage people/project issues
• Mature management skills demonstrated by calm and thorough review of situations.
• Seeks to understand all contributing factors.
• Proposes, implements, and evaluates appropriate, creative resolutions.
• Demonstrates the ability to define and meet project requirements

Benefits:

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)

• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.

#LI-Remote #LI-DF1

Expected salary:

Location: Canada

Job date: Thu, 09 Nov 2023 23:41:42 GMT

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Job description: opportunity for an experienced Trial Leader residing in the US, Canada or Mexico. Ideal candidates should have a combination… and/or Vaccine (Covid specific) clinical trials. Location: Remote role for candidates residing in US, Canada, or Mexico Travel…

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Location: Canada

Job date: Thu, 09 Nov 2023 23:45:22 GMT

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Job description: analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory…. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans…

Expected salary:

Location: Gwynedd, PA – Wales

Job date: Sat, 11 Nov 2023 06:18:37 GMT

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