Innovaderm Research is hiring Project Manager

Location: India

The project manager has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials or its portion conducted in EU or APAC regions. The project manager oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline). In this role project manager may be also responsible for overseeing activities managed by subCROs, especially in terms of providing deliverables and assessing the overall performance.

This role will be perfect for you if:

.Wish to work on multisite clinical trials, including Global Phase III projects.
.You have at least 5 years’ industry experience, including a minimum of 3 years leading multi-site clinical trials (Phase II-
III).
.You are looking to position yourself in an environment where you can grow your career alongside of a growing company.

Education: B.Sc. in a related field of study to clinical research.

Experience

.At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management.
.Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.
.Experience managing dermatology trials an asset.
.Proven experience in managing projects containing APAC component having in its scope at least Japan, Australia and South
Korea.
.Proven experience in managing projects executed in partnership with subCRO(s).

Knowledge and skills

.Very strong leadership, accountability and communication skills.
.Excellent knowledge of GCP and ICH standards, FDA and local country regulations[A1].
.Excellent knowledge of Microsoft Office suite.
.Fluency in English with excellent oral and written skills, required.
.Bilingualism (English and local language) is an asset.
.Ability to work in a team environment and establish good relationships with colleagues and sponsors.
.Good problem-solving abilities.
.Strong ability to carry out different projects and work under pressure while meeting timelines.
.Good knowledge of ICH guideline, applicable European Medicines Agency (EMA), Health Canada and Food and Drug Administration
(FDA) regulations/guidelines.

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