Clinical Data Manager/Senior Clinical Data Manager - Remote

Southern Star Research

Australia

Remote

AUD 80,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Attractive remuneration and benefits package

Genuine work-life balance

Solid career pathways and progression

STAR day – an extra day off per year

Job summary

A leading Australian CRO is seeking a Clinical Data Manager/Senior Clinical Data Manager. This remote role involves coordinating data management tasks across various therapeutic areas while promoting a positive work environment. Ideal candidates will have a strong background in medical disciplines and data management experience.

Qualifications

Minimum of 2 years' experience as a Data Manager in a CRO or Pharmaceutical Company.
Knowledge of ICH-GCP, GCDMP, and CDISC guidelines.
Ability to deliver work according to study timelines.

Responsibilities

Coordinate and lead study start-up tasks.
Develop the Data Management Plan and train staff.
Perform data cleaning and prepare databases for analysis.

Skills

Attention to detail

Communication skills

Organization skills

Teamwork

Adaptability

Education

Tertiary qualifications in medical, pharmaceutical or healthcare disciplines

Tools

Zelta

Viedoc EDC

Job description

Clinical Data Manager/Senior Clinical Data Manager - Remote

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Clinical Data Manager/Senior Clinical Data Manager - Remote

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Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia and New Zealand.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented Clinical Data Manager/Senior Clinical Data Manager to join our team in Australia.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About The Role

Reporting to the Data Management Team Leader, you will be responsible for:

Coordinating, performing and leading study start up tasks;
Reviewing CRF design;
Developing the Data Management Plan;
Specification of consistency checks;
Performing user acceptance testing;
Developing data transfer specifications;
Developing and working to plans and procedures;
Planning, executing and coordinating data cleaning activities including;
Generation of data queries;
Performing manual checks;
Reconciliation of data from electronic sources;
SAE reconciliation;
Medical coding;
Preparing the database for locking, ready for analysis;
Delivering training to internal staff as well as sites, clients and vendors; and
Perform additional duties as assigned.

To be successful in the role, we’re looking for candidates with:

Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines;
A minimum of 2 years’ experience as a Data Manager in a CRO or Pharmaceutical Company;
Experience with Zelta or Viedoc EDC is preferred;
A good working knowledge of ICH-GCP, GCDMP, CDISC and Biometrics related guidelines;
A demonstrated ability to work well in a team, be adaptable and flexible, with a positive attitude and a willingness to learn;
Superior organisation and planning skills and the ability to deliver work according to study timelines and within the project budget;
A high level of written and verbal communication skills; and
An exceptional level of attention to detail

Why Southern Star Research?

Southern Star Research is a growing business and this is an ideal opportunity for someone who is looking to progress their data management skills by being involved in all aspects of data management across a range of different therapeutic areas. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We Offer

An attractive remuneration and benefits package;
Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
Solid career pathways and progression in a growing company
Career stability and security;
Head Office located in Gordon, Sydney - Under cover parking provided and close to public transport; and
STAR day - one extra day off per year to recharge.

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Seniority level