Study Start-Up Leader

Posted 5 Hours Ago
Be an Early Applicant
Singapore
1-3 Years Experience
Pharmaceutical
The Role
Manage the study start-up process, develop strategies, coordinate critical path planning, collaborate with global study team, participate in client meetings, identify and mitigate risks, maintain systems, deliver client-focused reporting
Summary Generated by Built In

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.

Job Description

• Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.

• Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
• Collaborate and communicate within the Global study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities.
• Participate in client meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics.
• Partner closely with both Functional Leaders and Local Site Managers to proactively identify study start up related issues
• Develop and execute corrective actions to mitigate risks to activation timelines
• Ensure that relevant - systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level).
• Deliver and maintain client-focused reporting to measure performance and proactively identify issues for resolution

The Company
HQ: Durham, North Carolina
20,524 Employees
On-site Workplace

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.

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