start-up clinical research AssociatePPD

About us:
PPD's mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Start Up Operations
Our goal-driven teams combine and deliver start up activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start up timelines and exceed expectations.
About the role:
You will be primarily involved in the start-up of clinical trials conducted in the Philippines. You will manage the preparation, review, and coordination of country submissions and start-up activities. This role also covers activities related to feasibility and site evaluation.
Main duties and Responsibilities include:
Prepare, review and coordinate local Regulatory and Ethics Submissions in alignment with global submission strategy
Provide local Regulatory and strategy advice
Act as a key site contact on a country level for start-up related activities and provide oversight for projects in Sweden and Norway
Support the coordination of feasibility and site evaluation activities in accordance with guidelines: serve as the local expert regarding site capacity and expertise and work with key local personnel to gather knowledge base and recommend sites
Perform pre-study (evaluation) visits at local sites
Coordinate, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines
Prepare regulatory compliance review (Regulatory green light) packages
Qualifications
About you:
Sounds like an interesting job for you? If you have met the following criteria, then you're the one we've been looking for!
Qualifications and Experience:
University degree in a health/science-related field or certified health care training or equivalent experience
Experience as a site monitor is an advantage
Demonstrated experience in start-up activities (EC and CA submission management; ICF customization)
Knowledge in PH regulations
Understanding of ICH GCP
Fluent in English, both written and spoken
Ability to work in a team or independently as required
Effective communication and interpersonal skills
Strong attention to detail
Customer focus
Must be willing to do onsite visits when required
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
PPD

Philippines
Permanent
Full-time