In-Demand Study start up lead Jobs in Sydney, Nsw

Study Start Up Lead
TFS HealthScience —Sydney NSW
- Contract
- Remote
- Nursing
- Bachelor's degree
- Computer skills
Quick Apply
2d
Start Up Lead APAC
Precision for Medicine —Sydney NSW
- Remote
- Management
- English
- Bachelor's degree
Quick Apply
Partnerships Specialist
Sleek —Sydney NSW
- $85,000 - $120,000 a year
- Full-time
- Hybrid work
- AI
- Annual leave
- Work from home
Quick Apply
Research Executive - INN
Ipsos —Sydney NSW
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee assistance program
Business and Executive Support Officer
NSW Health —St Leonards NSW
- $114,251 - $134,809 a year
- Part-time
- Hybrid work
- Analysis skills
- Parental leave
3d
Senior Research Executive - Employee Experience
Ipsos —Sydney NSW
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee assistance program
Student Experience Domestic Team Leader
EDU Corporate Services Pty Limited —Sydney NSW
- Full-time
- CRM software
- Management
- Databases
Quick Apply
Café Supervisor
Max Brenner Australia —Macquarie Park NSW
- Up to $26.70 an hour
- Part-time
- Hospitality
- Management
- Customer service
- Employee discount
Quick Apply
Accounts Assistant – Part-Time (Leading to Full-Time for the right candidate)
Firstclass.com.au —Sydney NSW
- Part-time
- Hybrid work
- Microsoft Excel
- Sales
- Customer service
- Opportunities for advancement
- Referral program
Internship or Work Experience
Firstclass.com.au —Sydney NSW
- Part-time
- Hybrid work
- Microsoft Excel
- Sales
- Customer service
- Opportunities for advancement
- Referral program
Study Contracts Manager - Cell Therapy
AstraZeneca —Macquarie Park NSW
- Hybrid work
- Finance
- Administrative experience
- Analysis skills
Sales Team Leader
Firstclass.com.au —Sydney NSW
- $100,000 - $150,000 a year
- Part-time
- Hybrid work
- Microsoft Excel
- Sales
- Customer service
- Opportunities for advancement
- Referral program
Tax Undergraduate Analyst
Alvarez & Marsal —Sydney NSW
- Part-time
- Master's degree
- Bachelor's degree
- Business
Airfare Specialist
Firstclass.com.au —Sydney NSW
- Part-time
- Hybrid work
- Microsoft Excel
- Sales
- Customer service
- Opportunities for advancement
- Referral program
Clinical Trial Coordinator
St Vincent's Health Australia —Inner West NSW
- $114,251 - $134,809 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Office
9d
Full Stack Web Developer (Intern)
Firstclass.com.au —Sydney NSW
- Part-time
- Hybrid work
- Microsoft Excel
- Sales
- Customer service
- Opportunities for advancement
- Referral program
Research Officer
The Garvan Institute of Medical Research —Sydney NSW
- Up to $108,000 a year
- Full-time
- Doctoral degree
- Research
- Education
- Parental leave
Clinical Trial Coordinator
NSW Health —Darlinghurst NSW
- $114,251 - $134,809 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Office
9d
Business Analyst - Process Improvement
Evolution Mining —Sydney NSW
- Finance
- Business
- Accounting
- Life insurance
- Referral program
Sales Lead / Sales Manager (Path to Head of Sales - Australia)
Sleek —Sydney NSW
- Full-time
- Hybrid work
- CRM software
- Sales
- Bachelor's degree
- Annual leave
- Work from home
Quick Apply
10d

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Study Start Up Lead

TFS HealthScience -
Sydney NSW

Quick Apply

Job Details

Contract
2 days ago

Qualifications

Nursing
Clinical experience
Bachelor's degree
Computer skills
TFS
Communication skills

Full Job Description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Study Start Up Lead in Australia (home based)
- 1 FTE for next 3 months, then 0.2 FTE for additional 3 months -

About this role

As part of our CDS -Dermatology, Inmunology, Internal Disease area- team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Study Start Up Lead is responsible for coordination and overview of startup activities from projects are awarded till last participant site is activated, ensuring the startup deliverables and timelines are achieved.

The Study start up lead will work in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.

The Study start up lead will plan and pro-actively coordinate, together with the study PM, the study startup activities to ensure key milestones are achieved and start up is performed within budget, on schedule and in compliance with the appropriate - quality standards.

Key Responsibilities:

Ensure all startup activities for projects are performed on-time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
Together with the study Project Manager, manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan.
May oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites liaison. This case will ensure all assigned SSU Specialist are adequately trained on project specific systems and procedures.
Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached.
May manage the resource allocation of Start Up team on the project, in collaboration with respective line managers.
Responsible of coordinating EC/IRB submissions or any other notification requested as well as coordination with Regulatory department regarding HA/CA submissions/notification.
Ensure and oversight the proper aadaptation of Subject Information and Informed Consent documents according to local law and requirements.
Together with the Legal Department, coordinate the Clinical trial Agreements negotiation supporting the SSU Specialists and CRAs on handling the negotiation properly and on time.
Coordinate site evaluation and feasibility process for assigned projects.
Ensure all Start Up documentation is submitted properly and on time to the Trial master File.
Assist the Project Manager ensuring the Project is properly set up in CTMS and all information related to start up activities is properly updated.
Support the Project Manager coordinating the greenlight and site activations process and ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized, and specific project deliverables are completed.
Measure and evaluate project startup deliverables and metrics.
Update the Project Manager with status of start-up progress and ensure a proper escalation of any issue detected.

Qualifications:

Bachelor’s Degree, preferably in life science or nursing; or equivalent.
Minimum 4 years of experience in any relevant Clinical Operations experience related to Start Up procedures.
Able to work in a fast-paced environment with changing priorities.
Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
Ability to work independently as well as in a team matrix organization and multiple projects.
Excellent written and verbal communication skills as well as computer skills.
Excellent organizational and Line Management skills.
Ability and willingness to travel up to 10-20%

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.

Quick Apply

Refine Your Search

study start up lead jobs in sydney, nsw

Study Start Up Lead

Start Up Lead APAC

Partnerships Specialist

Research Executive - INN

Business and Executive Support Officer

Senior Research Executive - Employee Experience

Student Experience Domestic Team Leader

Café Supervisor

Accounts Assistant – Part-Time (Leading to Full-Time for the right candidate)

Internship or Work Experience

Study Contracts Manager - Cell Therapy

Sales Team Leader

Tax Undergraduate Analyst

Airfare Specialist

Clinical Trial Coordinator

Full Stack Web Developer (Intern)

Research Officer

Clinical Trial Coordinator

Business Analyst - Process Improvement

Sales Lead / Sales Manager (Path to Head of Sales - Australia)

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