General Information

Job Advert Title
Business Operations Manager - Study Start Up
Location
Australia
Function/Business Area
Research
Department
Clinical Operational Excellence
Employment Class
Permanent

Description

Business Operations Manager - Study Start Up

About Astellas:

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

The Opportunity:

This role sits within our Clinical Operations business unit. Your role is to provide oversight and direction to team members for deliverables and to provide direct supervision for contract team members.

Your role sits within Clinical Operations Excellence (COE) and serves as an expert in Study Start Up (SSU) activities and strategy. Your position will be based remotely and located in Australia. This is a full-time permanent position.

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities:

  • You will manage and lead the day-to-day operations within Study Start Up to ensure completion of goals and objectives in compliance with GCP/ICH guidelines and other regulatory requirements.
  • Manage and may lead functional and cross-functional internal teams.
  • Be responsible and may be accountable for all activities associated with Study Start Up. This may include oversight of SSU activities from receipt of a potential site list to site activation, including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements.

Essential Knowledge & Experience:

  • Be experienced in pharmaceutical-related drug development or a direct equivalent.
  • Must know clinical trial conduct, including multi-center, global trials.
  • Must demonstrate strong knowledge of ICH/GCP guidelines and regulatory requirements.

Preferred Experience:

  • Knowledge of how to work autonomously and as a team.

Education:

  • Preferred bachelor’s degree in science, Business or equivalent.

Additional information:

  • This is a full-time, permanent position.
  • Position is based in Australia.
  • This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Sydney office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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