Clinical Trial Associate

3 weeks ago

Mulgrave, Victoria, Australia Bristol Myers Squibb Full time

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

Working within a cross functional team, the Clinical Trial Associate will manage the administrative and business activities related to the conduct of clinical trials (registrational and non-registrational studies) from study start-up to study closure. This role provides the opportunity to work across aspects of the clinical trial life cycle across a broad range of therapeutic areas including oncology, immunology, dermatology, rheumatology and hematology, with more in the pipeline. You will contribute to process improvements, while developing your skills within a collaborative, dynamic and fast paced environment.

Responsibilities

  • Enter necessary data and support data tracking in systems (i.e., CTMS, eTMF, SAP).
  • Support document management within the eTMF.
  • Upload documents into the eTMF and other document exchange portals including investigator site portals, also supporting the conduct of document quality checks.
  • Arrange drug and non-drug (Lab kits, ECG) importation to support study site where required.
  • Complete invoice review, site payment reconciliation activities and create fund/PO, while managing, tracking and executing payments and closing country/investigational site funds.
  • Collect and distribute documents to and from sites during study life cycle.
  • Coordinate study related documents (i.e., IB, Protocol, Site Informed Consent Forms, etc) for printing and binding.
  • Provide administrative support to the study team (i.e., study related mailing, bill processing, printing etc).
  • Obtain insurance certificates for clinical trials.
  • Complete debarment checks of investigators
  • Prepare On Site Investigator Files and other study related files, and distribute to sites.
  • Support equipment calibration and tracking where required.
  • Archive process handling at study closure.
  • Support distribution of Additional Label Forms (ALF) to sites.
  • Support Health Authority inspection and pre-inspection activities.
  • Support audit preparation and Corrective Action / Preventative Action preparation for local related issues.

Qualifications, experience and competencies

  • Degree within Life Sciences area, Administrative, Financial or Accounting related field
  • 1 - 3 years' experience in Clinical Research or related work experience.
  • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred
  • Additional complex software application related to clinical trial research (i.e. electronic data capture or patient diaries, interactive voice response, etc.) preferred.
  • Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.
  • Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
  • Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
  • Demonstrates ability to function independently.
  • General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.
  • Good verbal and written communication skills (both in English and local language).
  • Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management System (CTMS), Electronic Trial Master File System (eTMF), Document Exchange Portals)

#LinkedIn-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit ) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582315

Updated: :14:22.228 UTC

Location: Mulgrave-AUS

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.


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