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Associate Clinical Data Manager

4 weeks ago

Melbourne, Australia Novotech Asia Full time

Organization Description

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,000 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Employer Description

Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

**Minimum Qualifications & Experience**:
Graduate in a clinical or life sciences related field. At least three to six years' experience working in a Clinical Data Associate (or equivalent) role in a pharmaceutical industry or related role.

**Responsibilities**:
1. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are

2.Participates in project team meetings as required & Input into the preparation of RFPs in liaison with BD and the clinical team.

3.Liaison with the project team and client for preparing and maintaining data for all aspects of data management including:
a. Design and review of database structure, validation rules and consistency checks.

b. Operation of Clinical Data Management software for data entry of clinical trial result & all data cleaning/validation tasks

c. Development of all key Data Management Documents

d. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders

e. Assist in the development of protocols as required.

6.Perform accurate study financial projections and maintain monthly project financials.

7.Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general.

8.Participation in industry forum (conferences, professional association committee work etc) as a means of professional development as well as promotion of Novotech' s image in industry.

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