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Sr Clinical Research Assoc/Submissions Specialist - Start Up Team - Norway

Pharmaceutical Product Development (PPD)

Swede

Submission for the position: Sr Clinical Research Assoc/Submissions Specialist - Start Up Team - Norway - (Job Number: 183763)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:

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 Norway. 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 Norway as part of international projects. The role has aspects from both the CRA role - covering Feasibility, Site Selection Pre-Study Visits activities. You will also manage the preparation, review and coordination of country submissions and start up activities in Norway.

The role would suit an existing Submission Specialist or a CRA who may like to extend their actifvties to other Start-Up areas.

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: 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 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 sites in Norway 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:

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 Norway. 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 Norway as part of international projects. The role has aspects from both the CRA role - covering Feasibility, Site Selection Pre-Study Visits activities. You will also manage the preparation, review and coordination of country submissions and start up activities in Norway.

The role would suit an existing Submission Specialist or a CRA who may like to extend their actifvties to other Start-Up areas.

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: 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 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 sites in Norway 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 Norwegian regulations

• Understanding of ICH GCP

• Fluent in Norwegian and 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

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.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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 Norwegian regulations

• Understanding of ICH GCP

• Fluent in Norwegian and 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

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.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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 Clinical Research Assoc/Submissions Specialist - Start Up Team - Norway - (Job Number: 183763)

Job posted: 2021-03-01

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