Manager, Study Start Up
- Canada
- Study Start Up
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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:
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio
- Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
- Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
- Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
- Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Implements innovative and efficient processes which are in line with Novartis strategy
- Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.
- Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned
- In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
- Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light”
- Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required
- Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead
You are:
- Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Similar jobs at ICON
Salary
Location
United Kingdom
Department
Study Start Up
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Site Activation Partner you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114242
Expiry date
01/01/0001
Author
Amani YousefAuthor
Amani YousefSalary
Location
United States
Department
Study Start Up
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Lead Site Activation Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114527
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
Japan, Tokyo
Location
Osaka
Tokyo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinica
Reference
JR124677
Expiry date
01/01/0001
Author
Emma QuAuthor
Emma QuSalary
Location
Japan, Tokyo
Location
Tokyo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
ICONでは、私たちを際立たせるのが社員です。 多様なチームによって、私たちはより良い顧客パートナーとなり、患者さんの生活を前進させ、改善するという使命を果たすことができます。Own It文化は、個人として私たちを団結させ、組織として私たちを際立たせる4つの重要な価値観によって推進されています。それは、説明責任と分娩、コラボレーション、パートナーシップ、インテグリティです。 私たちは、あらゆる接点
Reference
JR124676
Expiry date
01/01/0001
Author
Emma QuAuthor
Emma QuSalary
Location
Japan, Tokyo
Location
Tokyo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
ICONでは、私たちを際立たせるのが社員です。 多様なチームによって、私たちはより良い顧客パートナーとなり、患者さんの生活を前進させ、改善するという使命を果たすことができます。Own It文化は、個人として私たちを団結させ、組織として私たちを際立たせる4つの重要な価値観によって推進されています。それは、説明責任と分娩、コラボレーション、パートナーシップ、インテグリティです。 私たちは、あらゆる接点
Reference
JR124675
Expiry date
01/01/0001
Author
Emma QuAuthor
Emma QuSalary
Location
United States
Department
Study Start Up
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Feasibility Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This role involves coordinating and managin
Reference
2024-114017
Expiry date
01/01/0001