Manager, Study Start Up

2 weeks ago

Remote, Canada ICON Clinical Research Full time

As a Manager, Study Start- Up you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

  • Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review and essential document package review.
  • Must have an in-depth understanding of study start-up activities and associated regulatory requirements.

En collaboration directe avec les centres de recherche, le titulaire de ce poste gérera et exécutera de manière indépendante les activités au niveau du centre associées au démarrage de l'étude, notamment la collecte des documents réglementaires, la préparation des documents de soumission éthique, l'examen du consentement éclairé et l'examen de l'ensemble des documents essentiels. Sous la supervision du responsable de la stratégie d'activation du centre, le responsable du démarrage doit avoir une connaissance approfondie des activités de démarrage d'une étude et des exigences réglementaires associées.

You are:

What do you need to have?

  • Bachelor's degree with a major in a related field (or equivalent experience) and at least 5 years of experience in study start-up In-depth knowledge of start-up processes and procedures
  • Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
  • Experience with investigative site start-up documents
  • Good understanding of clinical trial execution
  • Must be fluent in French

Key Competencies Required

  • Ability to work under pressure to meet deadlines
  • Self-motivated and ability to work well independently and in a team environment
  • Ability to effectively manage multiple priorities
  • Excellent verbal and written communication
  • Excellent project management skills
  • Excellent collaboration skills
  • Meticulous attention to detail and process-oriented

In addition to experience listed above:

  • Minimum of 8 years prior experience within a clinical role – for example Clinical Operations, Study Start Up, Clinical Team Manager - Highly preferred
  • Undergraduate degree (or its international equivalent - Or equivalent related industry experience) in clinical, science or health-related field from an accredited institution

ue devez-vous avoir?

  • Licence avec une spécialisation dans un domaine connexe (ou expérience équivalente) et au moins 5 ans d'expérience dans le démarrage d'études sur la connaissance approfondie des processus et procédures de démarrage
  • Doit posséder une bonne connaissance pratique de la CIH, de la FDA, du CEE/CEI et des autres réglementations/lignes directrices applicables
  • Expérience en matière de documents pour le démarrage de centres de recherche
  • Bonne compréhension des essais cliniques
  • Maîtrise de l'anglais et de la langue du pays d'accueil
  • Expérience dans le domaine de la mucoviscidose et/ou des domaines thérapeutiques complexes de préférence

Compétences clés requises

  • Capacité à travailler sous pression pour respecter les délais
  • Motivation personnelle et capacité à travailler de manière indépendante et en équipe
  • Capacité à gérer efficacement de multiples priorités
  • Très bonnes compétences de communication verbale et écrite
  • Excellentes compétences en gestion de projet
  • Excellentes aptitudes en matière de collaboration
  • Démontrer une attention toute particulière aux détails

En plus de l'expérience énumérée ci-dessus :

  • Au moins 8 ans d'expérience préalable dans un rôle clinique, par exemple dans les opérations cliniques, le lancement d'une étude ou en tant que chef d'équipe clinique, de préférence
  • Diplôme de premier cycle (ou son équivalent à l'échelle internationale, ou une expérience dans le secteur) dans un domaine clinique, scientifique ou lié à la santé d'un établissement accrédité

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.


  • Study Start-up Specialist

    4 days ago

    Remote, Canada Alimentiv Full time

    Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and...

  • Regulatory and Start Up Specialist

    5 days ago

    Remote, Canada Precision Medicine Group Full time

    **Position** **Summary**: The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed...

  • Country Trials Manager

    2 months ago

    Remote, Canada Parexel Full time

    Canada, Remote Canada **Job ID** R0000012476 **Category** Clinical Trials **ABOUT THIS ROLE**: **Accountability** **Activities** may include but are not limited to the following **SSU Country** **Level Delivery** - ________________ - Oversees the execution of: - Country level implementation of Start Up and Site Activation Plans - Country level...

  • Remote French-canadian Voice Readers for Study

    4 days ago

    Remote, Canada Wireless Testing Solutions Full time

    Position: French-Canadian Voice Readers for Speech Study App - Speech Impediments Welcomed - Remote **Job Description**: We are seeking native French-Canadian Voice Readers for all including with a Speech Impediment/Disability, to support a study app by providing diverse speech samples. The role involves reading aloud in both quiet and noisy backgrounds...

  • Local Trial Manager

    2 months ago

    Remote, Canada ICON Full time

    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...

  • Front/back Sales

    23 hours ago

    Remote, Canada UP SPEED FINANCE Full time

    UpSpeed Finance is one of the few financing platforms in Canada with access to over 19 financial institutions for Auto, Leisure, Marine & Recreational vehicles, and we are currently looking to expand our team in the region. As a Finance Manager, you will play a pivotal role in our dealership by managing the financing process from start to finish. You will...

  • Clinical Research Associate Ii

    1 week ago

    Remote, Canada Precision Medicine Group Full time

    **Position Summary**: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going...

  • Clinical Trial Manager Ii

    3 weeks ago

    Remote, Canada Syneos - Clinical and Corporate - Prod Full time

    **Description** **Clinical Trial Manager II** 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 the patient...

  • Remodeling Sales Specialist

    2 months ago

    Remote, Canada Bath Tune-Up South Calgary Full time

    **Join a Rapidly Growing Team!** Are you a motivated professional seeking a stable, well-paying career? Bath Tune-Up, a leader in the remodeling industry, is expanding at an exciting pace and looking for dedicated team members to complete extraordinary bathroom remodeling projects. **Why join us?** - Competitive salary range: $75,000 - $95,000 - Steady...

  • Local Trial Manager

    4 weeks ago

    Remote, Canada ICON Clinical Research Full time

    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...

  • Local Trial Manager

    2 weeks ago

    Remote, Canada ICON Clinical Research Full time

    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...

  • Project Manager

    3 weeks ago

    Remote, Canada Centricity Research Full time

    Position Title: Project Manager Department: Research Reports To: Senior Research Management Direct Reports: President, Research POSITION FUNCTION The Project Manager will function to support project management within the Research Department. This will include project management coordination and tracking of new site start up, growth of existing sites,...

  • Site Activation Partner

    2 weeks ago

    Remote, Canada ICON Full time

    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...

  • Local Trial Manager

    4 weeks ago

    Remote, Canada ICON Clinical Research Full time

    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...

  • Clinical Research Associate- Sponsor Dedicated

    4 weeks ago

    Remote, Canada IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Research Associate- Sponsor Dedicated

    23 hours ago

    Remote, Canada IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Sales Enablement Manager

    3 weeks ago

    Remote, Canada 360Learning Full time

    The Sales Enablement team is a key player in ensuring 360Learning’s growth. The team is instrumental in ensuring all North America & EMEA Sales teams are fully equipped to hit the ground running and surpass their targets quarter after quarter. As Enablement, we provide the sales organization with the information, training, content, and coaching they need...

  • Grid Modernization Manager

    2 weeks ago

    Remote, Canada Electric Power Engineers Full time

    Overview: **We are designing the Grid of the** **future** We are innovators by nature **, **for over 50 years, Electric Power Engineers, LLC (EPE) has partnered with power and energy clients across the globe to focus on complex engineering and grid modeling challenges. As an early leader in the renewables space, we continue to see significant opportunities...

  • Project Director

    1 week ago

    Remote, Canada Innovaderm Research Full time

    **This role will be perfect for you if**: - Have an extensive project management experience within CRO environment, - Have a good understanding of a project financial flow and its specifics, - You were previously exposed to building the project operational strategy, business proposals and attending bid defense meetings, - You are a hands-on leader with...

  • Project Manager

    2 days ago

    Remote, Canada Centricity Research Full time

    Position Title:Project ManagerDepartment:ResearchReports To:Senior Research ManagementDirect Reports:President, ResearchPOSITION FUNCTIONThe Project Manager will function to support project management within the Research Department. This will include project management coordination and tracking of new site start up, growth of existing sites, growth of...