Project Manager (India)

5+ years

Not Disclosed

India

11 Nov. 24, 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

Position: Project Manager
Company: Innovaderm
Location: Home-based (Flexible work schedule)

Overview

Innovaderm is looking for a Project Manager to oversee and coordinate the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials or portions thereof, primarily conducted in the EU or APAC regions. This role is responsible for ensuring compliance with the study budget, scope, timelines, and applicable regulatory requirements. The Project Manager acts as the main point of contact for stakeholders and is involved in feasibility, study design, budget development, and progress reporting.

Responsibilities

Study Management

Serve as the primary contact for the Sponsor, vendors, and the internal team throughout the study.
Ensure studies are always "audit-ready" (training records, central files, system validation).
Manage trial timelines, budgets, resources, and vendors; coordinate tasks and deliverables across functional departments.
Control project budgets by reviewing time allocation, managing billable hours, and identifying out-of-scope activities for change orders.
Provide regular updates to stakeholders regarding site selection, vendor selection, trial progress, and timelines.
Lead the study start-up process, including Trial Kick-off meetings, site selection and activation, vendor set-up, and site contracting.
Implement risk management strategies to assure project quality and escalate issues to management when necessary.

Quality Control and Risk Management

Monitor the quality of study deliverables, including those from vendors and subCROs, addressing any quality issues with the appropriate team members.
Analyze discrepancies between planned and actual results and implement corrective actions.
Ensure all project-specific training matrices are customized and maintained.
Review and approve responses to quality assurance audits in line with SOPs and regulatory requirements.
Ensure study-specific documents (protocols, informed consent forms, eCRFs, etc.) are developed on time and meet study requirements.

Documentation and Reporting

Ensure all project-level study documentation is filed in the Trial Master File (TMF) in accordance with SOPs and regulatory requirements.
Maintain accurate and current TMF documentation throughout the study.
Report project status updates to internal and external stakeholders, ensuring compliance with the study budget, scope, and timelines.
Manage recruitment status and implement initiatives to mitigate slippage in recruitment timelines.
Participate in Investigator's Meetings and support the Regulatory Affairs team to ensure timely submissions.

SubCRO and Site Support

Oversee the work of subCROs, ensuring deliverables are provided on time and meet required quality standards and KPIs.
Collaborate with the Director of Project Management to build and maintain relationships with APAC subCRO partners.
Ensure that sites have all the necessary materials and equipment to perform the study.

Team Leadership

Mentor and provide technical, therapeutic, and project management expertise to junior staff.
Support ongoing learning and development for the team.

Ideal Profile

Education

B.Sc. in a relevant field of clinical research.

Experience

At least 5 years of industry experience, with a minimum of 3 years in Phase I-III clinical trial project management.
Experience in managing concurrent multi-center clinical trials with budgets exceeding $3M USD.
Experience in dermatology trials is an asset.
Proven experience managing trials with an APAC component (Japan, Australia, South Korea).
Experience working with subCROs is a plus.

Skills

Strong leadership, accountability, and communication skills.
Extensive knowledge of GCP, ICH standards, FDA regulations, and local country regulations.
Proficiency in Microsoft Office suite.
Fluency in English, with excellent oral and written skills (bilingualism is an asset).
Ability to work well in a team environment and establish relationships with colleagues and sponsors.
Strong problem-solving abilities and ability to work under pressure to meet deadlines.

About Innovaderm

Innovaderm is a Contract Research Organization (CRO) specializing in dermatology, with a reputation for delivering high-quality research and services since 2000. Headquartered in Montreal, Innovaderm continues to expand across North America and Europe.

Perks

Flexible work schedule and home-based position.
Ongoing learning and development opportunities.

Equal Opportunity

Innovaderm is committed to providing equitable treatment and equal opportunities. Accommodations are available during the recruitment process for applicants with disabilities, upon request.

Legal Eligibility

Innovaderm only accepts applicants who can legally work in India.

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