Mission
The company’s mission is to establish its blood-based test for early diagnosis of pancreatic cancer as a standard amongst pancreatologists and diabetes physicians worldwide for detecting pancreatic cancer in high-risk groups much earlier than is possible today.

Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden.

Immunovia’s strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia´s core technology platform, IMMray®, is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray® PanCan-d that could be the first blood based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. The first test from this program, IMMray® SLE-d, is a biomarker signature derived for differential diagnosis of lupus, now undergoing evaluation and validation.

The headquarter is based at Medicon Village in Lund, Sweden. Today, there are 37 employees in total, of which 7 in Boston, USA. Immunovia’s shares (IMMNOV) are listed on Nasdaq First North in Stockholm and Wildeco is the company’s Certified Adviser.

For more information about the company, please visit http://www.immunovia.com.
Clinical Study Manager
Company: Immunovia AB
Role: Clinical Study Manager
Reporting to: Chief Scientific Officer (CSO)
Place of position: Lund, Sweden

The role as Clinical Study Manager

We are looking for a Clinical Study Manager with very good knowledge of clinical trial methodology, to lead and participate in the planning and implementation of the clinical development program in Immunovia’s projects, including risk assessments, impact assessments and budget forecasts. This is an important role for the company as you will be coordinating clinical study activities that are a vital part of the development of Immunovia’s tests. Project management skills are essential to be successful.
The duties include developing clinical study protocols and plans, in consultation with Key Opinion Leaders (KOLs), CROs and the Chief Scientific Officer. You will write study documentation (including protocols and reports), be involved in selection and contracting of CROs, as well as coordination of CROs and other involved to deliver the clinical studies in set timelines, within budget and with highest achievable quality. The role involves interactions with internal stakeholders, external study sites and other support organizations e.g. CRO’s at an international level, which places high demands on the understanding of different cultures as well as great diplomatic skills.
You should have excellent knowledge in clinical studies for medical devices related to clinical study methodology, GCP, regulatory requirements and SOPs. You will work closely with the marketing department.
You have a strong drive with the ability to take initiative and you are good at communicating. Since the company is small, you must have a "can do" attitude and not be afraid to roll up your sleeves. You are independent, but also like the coordinating and project leading role for a team, working toward a common goal.

You will work in a smaller team of both internal and external people, and report directly to the Chief Scientific Officer.

Key responsibilities

The Clinical Study Manager will have responsibility for coordinating clinical study activities for Immunovia’s clinical programs. Responsibilities include:

• Project management in clinical development programs
• Assisting the management team with expertise in clinical trial methodology
• Reporting clinical study activities in Immunovia’s different project steering groups
• Participate and support Immunovia’s projects in areas where clinical coordination and planning is essential
• Develop clinical development plans, plan, outsource and follow up clinical studies so that delivery is done according to set goals
• Oversee clinical study programs and needed documentation. Write protocols, reports and other necessary study documentation.
• Monitor Immunovia’s study site agreements for compliance with budget and other agreed obligations
• Monitor clinical study sites activities
• Communicate with study sites on plans, documentation, reporting and in situations where a CRO is supporting a clinical study, oversee their activities in relation to the study and study sites.
• Responsible for procurement and contacts with CROs / consultants
• Build and maintain strong relationships with the study sites
• Maintain and develop document archiving in designated server systems
• Follow the development of processes and methods used internationally in relation to clinical studies that are similar to Immunovia’s program. Monitor the regulatory landscape and its impact on clinical studies. Contribute to the development of SOPs.


Required Qualifications and Skills

• BSc or MSc or equivalent working experience in life science/diagnostic companies/MedTech/Pharma/BioTech
• The role requires relevant experience of clinical study activities in preferably diagnostic companies, but similar experience from BioTech, Pharma, MedTech or advanced academic institutions is also considered
• Experience from IVD studies is an advantage
• Selection and contracting of subcontractors/CRO is an advantage
• Experience in project management
• Excellent knowledge in English, both in speech and in writing
• Computer skills (Microsoft Office)


Professional and Personal Competences

• Ability to network and establish partnerships and collaborations
• Excellent verbal and written communication and presentation skills at all levels of the organization
• Excellent listener and communicator with intercultural skills
• Action oriented personality capable of prioritizing activities to accomplish goals and objectives for important tasks
• Ability to deliver within a set timeframe and work in a dynamic fast-paced environment
• Ability to work in a team and share responsibilities and tasks
• Analytical with ability to tackle problems and take actions
• Develops job knowledge and expertise through continual professional development


Opportunities with the role

Immunovia is taking the next important step in bringing a solution to the unmet need of early detection of pancreas cancer to the market, by development of a world leading technology from Lund university to a clinical laboratory testing for early diagnosis of pancreatic cancer. You will contribute by planning and coordinating clinical study activities that are a vital part of the development of Immunovia’s tests. You will be part of a dedicated team working towards Immunovia’s vision
to significantly improve the survival rates, choice of treatment and life quality of cancer patients and their families.

You will join a growing organization that puts people in focus, with an engaged management team in a company with short decision-making processes. There is an informal and personal atmosphere where each employee's contribution is important for the company's development and results. Be part of a company characterized by a fantastic team feeling and where they have mandatory “fika med knäckebröd” every day.

Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Recruitment consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0)706 152 772
eva.runnerstrom@peaksearch.se, +46 (0)701 725 379
http://www.peaksearch.se

Application

Apply for the position at http://www.peaksearch.se