Clinical Research Associate (CRA) or Lead CRA

Om jobbet

Would you like to be part of a growing biopharma company?

Hansa Biopharma is a fast-growing biopharmaceutical company that is developing immunomodulatory treatments for enabling transplantations, rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy and cancer. The Company's lead product candidate, imlifidase,has been granted conditional approval in the European Union to desensitise highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor. Commercial launch of imlifidase in select European countries is ongoing.

Hansa's research and development program is also advancing the Company's enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, rendering them suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and has operations in other European countries and the US.

Position:Clinical Research Associate (CRA) or Lead CRA

We are currently looking for a highly skilled and motivated CRA or Lead CRA, named Clinical Research Coordinator (CRC) at Hansa, to share our mission to execute clinical trials in an innovate, high quality and compliant manner to improve and save lives around the world. As a CRC, you will have considerable responsibility and play an important part in ensuring successful clinical trial activities sponsored by Hansa Biopharma AB in close collaboration with other internal trial team members and the selected Contract Research Organization (CRO).

You can be involved simultaneously in several trials and you will be part of the Clinical Operations team that today consist of 30 highly skilled and motivated persons. You will report to the Team Lead of the CRC group and the respective Clinical Research Manager (CRM )for trial activities. The position requires some travel related to clinical trial activities/meetings, international conferences and other relevant meetings.

As part of our cutting-edge research, you will have a tangible impact on patients on the exciting journey that Hansa Biopharma has embarked upon.

We would like the candidate to have at least five years of experience working with clinical trials and good knowledge in ICH-GCP in the pharmaceutical/biotech industry or in a CRO, preferably experience working as a CRA and as a Lead CRA.

Are you a highly motivated and skilled professional who wants to be part of and contribute to our/Hansa`s growth and our company`s and department development? This is a great opportunity for you!

Principal Responsibilities

• In collaboration with Hansa Trial Team ensure that the clinical trials are run in compliance with the Clinical Trial Protocol, ICH-GCP, FDA regulations and other applicable regulatory and legal requirements and implement applicable oversight plans to ensure this.
• Provide functional expertise and contribute to the overall trial conduct.
• Be sponsor representative attending Pre-Trial and Trial Initiation visits on site and in close collaboration with Hansa Trial team and applicable CRO.
• Contribute to the Sponsor Trial Oversight Plan and ensure the trial activities are conducted according to plan, both outsourced and internal Hansa activities
• Perform on-site co-monitoring visits according to Sponsor Trial Oversight Plan or Ad Hoc, to ensure sites and ISF are inspection ready and take applicable actions to mitigate issues and challenges.
• Perform site motivational activities/visits to enhance the recruitment in our Clinical Trials, in collaboration with the CRO and/or with other applicable Hansa stakeholders.
• In collaboration with Hansa Clinical Trial Team contribute to and conduct CRA (the CRO CRAs) training and motivational activities according to plan and when applicable.
• In collaboration with Hansa Trial Team oversee, follow-up and document outsourced clinical trial activities, as applicable and according to Sponsor Trial Oversight Plan.
• Create or review applicable working manuals/ documents/plans dependent of the needs and what is outsourced (e.g., pharmacy manual, monitoring plan, lab manuals) and other trial documentation.
• Contribute to submissions of CTA/IND/Ethics committees/IRBs, including relevant documents.
• Contribute to the overall process for ordering, labeling and shipment of IMP within clinical trials in collaboration with Hansa Clinical Trial Supply Manager

Professional Qualifications

In order to succeed in this position, we believe that you should possess:

• Master's degree in life sciences or research nursing or equivalent
• Applicable training in Clinical Trials including ICH-GCP regulations and other relevant training for the position

The following experience is desirable:

• Five years of experience working with clinical trials and good knowledge and experience in ICH-GCP
• Previous experience working as a CRA/Lead CRA or similar and experience in all phases of a trial's life cycle, including start up, conduct and close out.
• Experience of global phase III trials
• Background or experience working with RBQM and trial oversight activities at a small Biotech company is a plus
• Previous experience of conducting Co-Monitoring visits
• Experience in sponsor oversight activities

You as a person

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone's unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

• Very good collaboration and interpersonal and problem solving skills
• Very good verbal and written communication and presentation skills in English
• A positive to-do-attitude
• Very good planning skills and ability to handle the work in a proactive and successful way
• Take the responsibility on own tasks, and have the ability to work both independently and in teams
• Highly ambitious and motivated
• Would like to contribute to Clinical Operations and the company's growth and development

Our culture and behaviours

Working at Hansa is more than a job for us andour culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:

• Self-motivated
• Doer
• Team player

Our people mean everything to us, and soour leaders, in addition to the above, must also be able to evidence the behaviours below:

• Brave
• Empathetic
• Lead-by-example

All these behaviours will be assessed at various stages of the recruitment process.

Hansa is for everyone

At Hansa we aspire to be a truly great place to work.We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple - hire the best person for the job.

What we offer

• A position in a company thatenvisions a world where patients with rare immunological diseases lead long and healthy lives.
• The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people.
• An opportunity to build a fully integrated biopharmaceutical company with global outreach.
• An open-minded and welcoming atmosphere. We care about our employees and are immensely proud to have been certified "A Great Place to Work" by Great Place to Work®, a global authority on workplace culture, employee experience and leadership behaviour.
• Friendly, motivated and skilled colleagueswith whom you can both laugh and work.

Type of employment

This is a permanent and full-time (40 hours) position. Hansa Biopharma is based in Lund, Sweden and for this position we are looking for a candidate based in Sweden. Suitable candidates can be office or homebased.

The process

Please apply for the position through the following link. Applications should not be sent through any other platform.

Attach your CV and a cover letter in English only. Unfortunately we are unable to review applications made in other languages.

The last day for applications is April 26, 2023, but we will review applications as they are received and may ultimately close the process earlier.

For questions regarding the position and process,please contact the recruiting manager: Helene Rahdevi, [email protected]

We look forward to receiving your application - join us and make significant contributions to Hansa Biopharma's research!

Please note: No external recruitment support is required. Only applications received directly will be considered.

Department Clinical Operations Locations Lund Remote status Hybrid Remote

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