Instagram
youtube
Facebook

Project Manager

5+ years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position: Project Manager
Location: Melbourne, Victoria, Australia
Job Category: Project Management


Role Overview:

The Project Manager is responsible for overseeing the planning and management of all contracted responsibilities for assigned projects and acts as the primary contact between Novotech and its clients. The role ensures successful project delivery by coordinating efforts across various teams and managing timelines, budgets, and project risks.


Key Responsibilities:

As a Project Manager, you will:

  • Project Feasibility: Determine project feasibility in collaboration with Business Development, considering the sponsor's needs.
  • Guidance & Scope Management: Provide guidance, review scope of work, responsibilities, timelines, and quality of deliverables.
  • Contract & Risk Management: Understand the requirements of the Project Agreement and ensure that Novotech meets the standards, while addressing project risks with management.
  • Operational Planning: Set up and maintain project plans, timelines, study tracking tools (e.g., CTMS), and eTMF.
  • Vendor Management: Work with the Vendor Manager to assess, appoint, and manage study vendors, such as central laboratories, drug distributors, and IRT providers.
  • Cross-functional Coordination: Coordinate workstreams across various teams (Clinical, Regulatory, Medical, Biometrics, Pharmacovigilance).
  • Budget & Revenue Management: Manage study budgets and revenues according to the Master Services Agreement and Project Agreement.
  • Site Management: Select and manage investigational sites to meet client objectives and timelines.
  • Client Interface: Serve as the primary interface with the client and make study-related decisions based on the sponsor’s delegation.

Experience and Qualifications:

The ideal candidate should have:

  • At least 5 years of experience in the clinical research industry, with prior project management experience.
  • Global PM experience in late-phase clinical studies (preferably in Asia, Australia, and Europe).
  • CRO experience is an advantage.
  • A graduate degree in a clinical or life sciences-related field, or equivalent relevant qualifications/experience.

Desired Skills & Competencies:

  • In-depth understanding of clinical research processes and project management principles.
  • Strong leadership and organizational skills.
  • Ability to manage multiple stakeholders and work in a cross-functional team environment.
  • Excellent communication and problem-solving skills.
  • Experience with budget management and vendor relations.

About Novotech:

Novotech is a full-service Clinical Contract Research Organization (CRO) with a global presence. With over 3,700 clinical projects in its portfolio, Novotech provides clinical development services across all clinical trial phases, including Phase I to Phase IV clinical trials, bioequivalence studies, and drug development consulting. The company has a strong presence in the Asia-Pacific, North America, and Europe regions and offers comprehensive support for biotechnology and pharmaceutical companies.