Clinical Start-up Manager

We are looking for a Clinical Start-up Manager, who will take a leading role in managing various global study deliverables across studies. As Start-Up Manager, you will be responsible for supporting the Clinical Operations Manager/Director, and the clinical research organisations (CROs), with start-up activities for Phase I-III clinical trials. You will ensure that deliverables and knowledge are transferred between trials both within, but also across projects, to secure overall successful and timely study start-up. You will be a key player in a fast-growing cross-functional team and work closely with the clinical operations team, the Chief Medical Officer and colleagues across the organization.
Your main tasks
• Overall management and oversight of the following activities, such as site feasibility, site readiness, site contracts and coordination of study specific insurances.
• Responsible for escalations on negotiations of various confidentiality disclosure agreements and site clinical trial agreements, involved in development of master patient information (PI) and informed consent forms (ICF), review and approval of regional specific PI/ICFs and general input and communication with the CROs
• Support activities in relation to various study start-up activities with final goal of ensuring site regulatory green light.
• Might be involved in various operational excellence activities like process improvement or other line function initiatives.
Your qualifications
You hold a degree in a science-related field or an equivalent combination of education, training, and relevant experience.
We think you have:
• At least four years of relevant experience in clinical research organization, biotechnology/ pharmaceutical or equivalent healthcare industry.
• Demonstrated quality/compliance knowledge related to study startup
• Project Management skills: Leadership, Decision-making, Organization and Negotiation
• English: advanced level
• Valid GCP training
As a colleague and professional you
• Tackle demanding goals with enthusiasm in a collaborative manner; you build team spirit, recognise contributions from others and communicate proactively
• Demonstrate solid ability of adequate prioritization mindset, including excellent planning and organisational skills
• Deliver high standard on quality and quantity, and manage stakeholder expectations
• Demonstrate the ability to deal with complexity under pressure; keeps momentum through difficulties
• Considerable ability to develop and maintain productive relationships with coworkers, managers and clients
• You can work independently as well as in teams
• Are excited about Ascelia Pharma’s product portfolio and opportunities ahead and feel comfortable in working according to Ascelia Pharma’s values focus, courage and integrity.
Other information
Work location: Preferably able to work primarily from the head office; other locations considered depending on the candidate.
Swedish work permit is a requirement.
Domicile: Hyllie Boulevard, 215 32 Malmö, Sweden
How to apply
Please submit your resume and cover letter, along with any other material, via our portal as soon as possible. All applications must be in English and are treated confidentially.
Candidates will be assessed as applications are received. Only candidates considered will be contacted.
For more details about the job or the company, please contact Karin Liljeberg on +46 735-17 91 12 or kl[at]ascelia.com