Clinical Project Manager / Scpm (Cro Services)

2+ years

Not Disclosed

Remote, USA

10 Nov. 4, 2024

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

Job Title: Project Manager or Senior Project Manager
Location: Australia, Home-based

Job Overview:
The Project Manager is responsible for managing clinical trials, ensuring timely delivery of project objectives and adherence to client agreements and budget. This role involves overseeing compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH guidelines, and applicable regulations. The Project Manager acts as the primary liaison with the client, facilitating effective communication about project progress, issues, and resolutions.

Key Responsibilities:

Develop a clear and measurable project management plan in collaboration with the Director of Clinical Operations and Sponsor representatives.
Manage clinical projects, ensuring deliverables from all functional areas and vendors meet contractual timelines and quality standards.
Define timelines, milestones, and scope of work for project staff.
Establish project metrics and reporting schedules, providing monthly updates to clients.
Serve as the primary liaison between the project team and sponsors/customers.
Identify critical success factors for tracking and analyzing project risks.
Monitor project status and budget expenditures, recommending solutions to any identified issues.
Coordinate resource assignments for project execution and ensure adequate staffing.
Develop budget review strategies, create scope definitions, and implement cost containment measures.
Manage site contract and budget negotiations according to project timelines.
Review and approve project grants, expense reports, and financial records.
Oversee the development and delivery of project team training.
Communicate performance expectations and guidelines to the team.
Manage performance of service providers and delegate assignments to promote growth.
Contribute to the development and review of departmental SOPs and continuous process improvements.
Support business development by participating in project proposal development and representing Caidya at meetings.

Supervisory Responsibilities:

No direct supervisory responsibilities, but may mentor team members.

Job Requirements:

Education:

Bachelor’s degree preferred; advanced degree or equivalent clinical research experience is a plus.

Experience:

Minimum of 2+ years managing clinical trials in a Clinical Project Manager role or similar at a CRO.
5+ years in the clinical research industry.

Skills/Competencies:

Expertise in project management with a proven ability to manage projects and people effectively.
Proactive problem-solving skills and adaptability in a changing work environment.
Extensive knowledge of clinical research and drug development processes.
Strong communication and presentation skills, capable of maintaining positive relationships with sponsors and project teams.
Proficient in MS Office suite and project management software like MS Project.
Demonstrates professionalism and integrity, fostering teamwork and flexibility.

Capabilities:

Fluent in English, both verbal and written.
Infrequent travel may be required.

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Clinical Project Manager / Scpm (Cro Services)

Job Description

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