Programming Specialist/Principal Statistical Programmer

Jobbeskrivelse
Would you enjoy working with different projects and with the ability to influence your job? Then you should apply to us at Larix Clinical Operations. We are now seeking a Clinical Research Associate to join our office in Lund.

What you will do

At Larix, you'll be part of our Clinical Operations group in Denmark and Sweden. You will work from our offices in Lund but have the ability and willingness to travel inside and outside Sweden. Clinical Operations consists of experienced and enthusiastic Clinical Research Associates and Clinical Trial Managers responsible for the planning and conduct of clinical activities in the Nordic countries.

Your main tasks will include:

- Perform and handle all aspects of trial & site management of sponsor projects

- Be primary site contact and site manager

- Manage and perform monitoring and site management activities related to clinical trials in both pharmaceutical and medical device areas

- Perform remote and on-site monitoring & oversight activities

- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out

- Contribute to local submissions to EC and CA

- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

- Work closely with our Clinical Trial Managers (CTM) in ad hoc study management related tasks

- Prepare or contribute to the update of SOPs and procedures within Clinical Operations

- Travel days will approximately be 3-4 days per month

Who you are

We are looking for an experienced Clinical Research Associate - we will get to know you as a proactive and competent colleague who approaches projects with a team players' spirit. At the same time, you are very good at working independently and are able to plan, structure and drive your own tasks.

Moreover:

- You have a relevant background from life science

- Experienced in monitoring studies and investigator site management

- Up to date on ICH-GCP including national regulatory requirements

- Experience in submission to EC/CA

- You are an open-minded, cooperative, and service-minded person with a high-quality mind-set

- You have good communication skills

- Experience in medical devise study an advantage but not requirement

- Strong computer skills

- A client-focused approach to work and flexible attitude with respect to assignments/new learning

- You speak and write English and Danish effortlessly

Are you interested?

We would love to hear from you. To apply for this position, please forward your application and CV to job@larixcro.com or by applying here on LinkedIn using EasyApply. Applications will be handled by our Business Manager in the order they arrive.

Please note that vacancies will be filled on a rolling basis after opening and this job posting is also for our candidate pool for future job openings. Therefore, we highly recommend you submit your application as early as possible to be considered for the opportunity of your choice.

Who is Larix?

Larix A/S is a Nordic Contract Research Organisation (CRO) - we offer full-service solutions within the pharmaceutical, biotech and medical device areas. Our headquarters are located near Copenhagen in the middle of the Medicon Valley region, and we have strong ties to the thriving pharmaceutical and biotech activities in this region. We also have a smaller office at Medicon Village in Lund and a local presence in Oslo and Helsinki. Larix is a part of Alten Group and we work closely with our sister company (Aixial), which gives us all the advantages of being a small, agile and flexible company combined with support from a larger company when it comes to e.g. systems and resources.

At Larix, we maintain a friendly atmosphere - we think having fun while working is important, and we prioritize creating a work environment with a healthy work-life balance. We are a medium size company with approximately 70 employees, and we have all the benefits of being able to collaborate across functions, learn from each other and follow clinical study processes from start to finish.