Sr Submission Specialist/Sr CRA (Start Up Team) - Finland

Submission for the position: Sr Submission Specialist/Sr CRA (Start Up Team) - Finland - (Job Number: 179717)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.

Site Intelligence and Activation (Start Up Team):

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.

We have a new opening for the dual position of Senior Country Approval Specialist/Senior Clinical Research Associate (CAS/CRA) in our Start Up team in Finland. This role will be fully homebased and be affiliated to our office in Sweden. This is a permanent, full-time position.

You will be primarily involved in start-up of clinical trials conducted in Finland as part of international projects. You will manage the preparation, review and coordination of country submissions and start up activities in Finland.

This role also covers activities related to feasibility and site evaluation.

With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have good knowledge of EU and local regulations and ICH GCP requirements.

Main duties and Responsibilities include:

Act as a key site contact on a country level for start-up related activities and provide oversight for projects in Finland 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 sites in Finland 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

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.

Site Intelligence and Activation (Start Up Team):

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.

We have a new opening for the dual position of Senior Country Approval Specialist/Senior Clinical Research Associate (CAS/CRA) in our Start Up team in Finland. This role will be fully homebased and be affiliated to our office in Sweden. This is a permanent, full-time position.

You will be primarily involved in start-up of clinical trials conducted in Finland as part of international projects. You will manage the preparation, review and coordination of country submissions and start up activities in Finland.

This role also covers activities related to feasibility and site evaluation.

With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have good knowledge of EU and local regulations and ICH GCP requirements.

Main duties and Responsibilities include:

Act as a key site contact on a country level for start-up related activities and provide oversight for projects in Finland 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 sites in Finland 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 and Experience:

University degree in a health/science-related field or certified health care training or equivalent experience Experience as a Clinical Research Associate Demonstrated experience in start-up activities (EC and CA submission management; ICF customization) Deep knowledge in EU and Finnish regulations Understanding of ICH GCP Fluent in Finnish and English, both written and spoken Fluent in Swedish, both written and spoken, is considered an advantage Ability to work in a team or independently as required Effective communication and interpersonal skills Strong attention to detail

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

#LI-MC2

#LI-Remote

Qualifications and Experience:

University degree in a health/science-related field or certified health care training or equivalent experience Experience as a Clinical Research Associate Demonstrated experience in start-up activities (EC and CA submission management; ICF customization) Deep knowledge in EU and Finnish regulations Understanding of ICH GCP Fluent in Finnish and English, both written and spoken Fluent in Swedish, both written and spoken, is considered an advantage Ability to work in a team or independently as required Effective communication and interpersonal skills Strong attention to detail

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

#LI-MC2

#LI-Remote

Submission for the position: Sr Submission Specialist/Sr CRA (Start Up Team) - Finland - (Job Number: 179717)