Mgr, Ssu & Regulatory, Fsp Apac

2+ years

Not Disclosed

Remote Australia

10 Dec. 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Site Start-Up & Regulatory
Location: Australia-Asia Pacific (Home-Based)
Job ID: 24006330
Updated: November 28, 2024

Job Description

Manager, Site Start-Up & Regulatory
Syneos Health® is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success. By leveraging unique clinical, medical affairs, and commercial insights, we address the modern realities of the market.

Our Clinical Development model places the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline our processes to ensure that Syneos Health is not only easier to collaborate with but also a great place to work for.

In both Functional Service Provider partnerships and Full-Service environments, you will join passionate problem solvers, collaborating as a team to help our customers achieve their goals. We are agile, motivated to accelerate therapy delivery, and deeply passionate about changing lives.

Join our global team of 29,000 employees across 110 countries and experience firsthand why WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

We are committed to developing our people by providing career growth opportunities, technical and therapeutic area training, and a strong focus on employee well-being. Our Total Self culture embraces authenticity, diversity, and inclusion, ensuring everyone feels valued.

Job Responsibilities

Oversee people management activities, including hiring, terminations, professional development, performance reviews, and employee counseling.
Provide guidance on administrative policies, technical issues, and process methodologies.
Act as a liaison between customer leaders and senior management, coordinating resources and priorities.
Support site start-up, maintenance, and financial management, with a focus on process improvements.
Assist with project and departmental reviews, monitoring budgets, schedules, and risk analysis.
Develop and deliver training programs for departmental teams.
Collaborate with executive management and the Legal Department on site contracts, start-up, and regulatory workflows.
Implement and maintain enterprise project management systems and tools.
Contribute to the creation and implementation of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for existing and new processes.
Ensure quality control across departmental teams.
Represent the company at professional meetings and seminars.
Establish and maintain training materials for assigned teams.

Qualifications

Bachelor’s Degree or equivalent experience.
Experience in clinical research, particularly in site start-up and contract management.
Strong knowledge of regulations, drug development processes, and clinical project management.
Excellent interpersonal, presentation, and documentation skills.
Proficiency in MS Office, MS Project, email, and internet use.
Ability to manage multiple tasks and meet deadlines in a dynamic environment.
Strong leadership and line management abilities, with a focus on coaching and performance management.
Ability to address and improve underperformance when necessary.

About Syneos Health

In the past five years, Syneos Health has supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000 trial participants.

At Syneos Health, we encourage initiative and innovation in a competitive, ever-evolving environment. Learn more about us and our impact.

Additional Information:

The tasks, duties, and responsibilities listed in this job description are not exhaustive and may be subject to change based on business needs. The company reserves the right to assign other tasks or responsibilities. Equivalent experience, skills, or education will be considered as part of the recruitment process. Syneos Health is committed to equal opportunities and workplace diversity and complies with all applicable local legislation, including the ADA and EU Equality Directive.

Apply Now

Not ready to apply?
Join our Talent Network to stay connected with future opportunities.

Syneos Health is an equal opportunity employer. If your qualifications don’t exactly match the position, we encourage you to apply anyway. Transferrable skills from previous roles are always considered.

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Mgr, Ssu & Regulatory, Fsp Apac

Job Description

Job Description

Why Syneos Health?

Job Responsibilities

Qualifications

About Syneos Health

Additional Information:

Apply Now

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