Study Startup Specialist II

Reposted 3 Days Ago
Be an Early Applicant
Hiring Remotely in Mississauga, ON, CAN
In-Office or Remote
Junior
Pharmaceutical
The Role
Lead country-level study activation by coordinating site activation, agreements, contract and budget negotiations, IRB/IEC and authority submissions, translations, IP distribution, site documentation exchange, and timelines to meet site activation targets.
Summary Generated by Built In
Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

You will: 

  • Collaborate with the project team for site activation processes
  • Facilitate site agreement, contract negotiations and budget negotiations
  • Collect site documents for IRB/IEC submission and/or IP-RED process
  • Coordinate translation and review of study-specific documents
  • Identify and escalate project-specific issues as needed
  • Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
  • Prepare IP-REDs packages
  • Support initial distribution of Investigational Product(s) and clinical study supplies to sites
  • Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
  • Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training and experience
  • At least 2 years of full-scope Study Startup experience.
  • Full professional working proficiency in English and French.
  • Well-developed communication and organizational skills
  • Ability to negotiate and build relationships at all levels

Additional Information

We offer:

  • Excellent working conditions
  • Extensive training and friendly team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Skills Required

  • College/University degree in Life Sciences or equivalent
  • At least 2 years of full-scope Study Startup experience
  • Full professional working proficiency in English and French
  • Well-developed communication and organizational skills
  • Ability to negotiate and build relationships at all levels
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The Company
HQ: Zug
1,939 Employees
Year Founded: 1995

What We Do

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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