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.
Key Accountabilities:
Study Management
Forecast timelines, budget & FTE resource ( if applicable).
Take a key leadership role in the management of studies’ timeline, quality, cost.
Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations.
Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track.
Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured .
Timely update projects information to the Brand Team.
Review and approve project relevant documents.
Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.)
Prepare and lead investigator and monitor meeting.
Ensure AEs/SAE reporting according to GCP and regulation.
Plan and lead activities associated with study level Quality Control plan.
Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate.
Provide operational support to the ESR investigators to ensure the on time delivery of ESR
Compliance with Parexel standards
Comply with required training curriculum.
Complete timesheets accurately as required.
Submit expense reports as required.
Update CV as required.
Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.
Skills:
Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out
Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization
Leadership skills
Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software.
Fluent in both oral and written English
Proven ability to deliver training
Knowledge and Experience:
Minimum 2–3-year experience of project management experience.
Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development
Read, write, and speak fluent English; fluent in host country language required.
Education:
Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background
Top Skills
What We Do
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.
