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Local Study Associate Director - FSP

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Salary: 
6 - 6K yearly
Experience: 
Mid-level (2-5 years)
Work from: 
Turkey

Offer summary

Qualifications:

Bachelor's degree in a related discipline, preferably in life science., At least 1 year experience as a Clinical Trial Leader or Project leader., Minimum 3 years of experience in Development Operations (CRA, SrCRA)., Experience in oncology trials..

Key responsabilities:

  • Lead Local Study Teams (LST) for clinical studies.
  • Ensure site identification, qualification, setup, and monitoring.
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
See more Parexel offers

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring an Associate Clinical Study Director to join us on a

permanent full-time, 3 days office based.

If you’re driven by the potential of science to create meaningful change and eager to explore your capabilities, join us.

Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every life sciences value chain segment. Their science-driven approach aims to transform healthcare and improve patient outcomes while fulfilling a purpose-led role in society.

As an Associate Study Director, you will lead Local Study Teams(LST) at the country level to deliver clinical studies according to agreed resources, budget, and timelines complying with procedural documents, international guidelines, and relevant local regulations. In addition to leading LST(s), ) may perform site monitoring as needed to support the flexible capacity model.

Responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA. Lead Local Study Team(s) consisting of CRAs, start-up specialists, and study administrator(s).

Essential Requirements

  • Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.

  • At least 1 year experience as a Clinical Trial Leader or Project leader.

  • Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).

  • Experience in oncology trials.

  • Good knowledge of international guidelines ICHGCP as well as relevant local regulations.

  • Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.

  • Excellent project management skills.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Apply today!

#LI-TA1

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Clinical Trial Management SystemsProject ManagementClinical TrialsCross-Functional Team LeadershipWebsite MonitoringRegulatory ComplianceBudget ManagementResource Management

Other Skills

  • Time Management
  • Communication
  • Self-Motivation
  • Empathy
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