Country Approval Specialist – Study Start-up Specialist (SSU)

  • Company:
  • Location:
  • Salary:
    negotiable / month
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  • Posted:
    15 hours ago
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PPD is recruiting for our growing Australian study start-up team. As one of the world’s largest CRO’s, our CRA’s have the opportunity to work on challenging projects across a wide range of therapy areas with some of the most innovative pharmaceutical and biotech companies in the world

PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading company amongst CROs and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.

Currently we are recruiting for a dual role for Country Approval Specialist/Contract Specialist.

*Role duties:*

* Provides Site Selection support for awarded multi-service projects

* Key-contact at country level for either Ethical or Regulatory submission-related activities.

* Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation

* Prepare, review and coordinate the local regulatory submissions (MoH, EC, additional special national local applications if applicable, import licenses etc) in alignment with the global submission strategy.

* Developed collaborative relationships with investigative sites and client company personnel.

* Negotiate and finalize site contracts and budgets as necessary

* Maintain regular site contact during the start-up phase and document all communications in CTMS.

* Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process

* Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.

*Education and Experience: *

* Bachelor’s degree or equivalent and relevant formal academic / vocational qualification

* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years’) or equivalent combination of education, training, & experience.

* Australian or New Zealand site knowledge advantageous

*Knowledge, Skills and Abilities:*

* General understanding of budget negotiations within Australia

* Basic understanding of contract and Indemnification requirements for Australia

* Effective oral and written communication skills

* Excellent interpersonal skills

* Strong attention to detail and quality of documentation

* Good negotiation skills

* Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

*Our offer*: As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.

Locations we are hiring in:

* Office based Melbourne, Australia

* Home based Australia


**Job:** **Site Startup*

**Organization:** **AU BU*

**Title:** *Country Approval Specialist – Study Start-up Specialist (SSU)*

**Location:** *AU-AU-Melbourne-Melbourne AU Queens Road*

**Requisition ID:** *175194*

**Other Locations:** *AU-AU-North Sydney-N Sydney AU Pacific Hwy*

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group