CLINICAL OPERATIONS MANAGER
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance® (Mangoral) and Oncoral – in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.
We are looking for a Clinical Operations Manager, who will take a leading role in managing international study deliverables as well as leading cross functional study teams, for orphan oncology drugs in development, and join our journey in building and growing the company to improve the lives of patients with rare oncology related diseases.
With direct report to the Director of Clinical Operations, you will be responsible for performing oversight activities of international studies and own the recruitment, retention and compliance strategy development for study opportunities. 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
Perform oversight activities, such as clinical research organizations (CRO’s) and vendors, site and quality oversight, with a risk based, quality management mindset.
Collaborate and own the recruitment, retention and compliance strategy development for study opportunities, including patient recruitment, vendor set-up and oversight, focusing on driving support to study sites, patient and caregivers to maximize recruitment
Developing and ensuring confidentiality, negotiation of study and site agreements and contracts with external vendors and sites
Support with investigational manufacturing products (IMP) Management; IMP supply vendor set-up, capabilities and resourcing capacity to assure efficient and compliant study medication demand and resupply planning, Interactive Response Technology (IRT) set-up and distribution
To master the position as Clinical Operations Manager, you need a track record in international study manager roles (or similar) from a pharmaceutical company or a CRO.
You hold a master’s degree from a relevant field of study within life science, or are a registered nurse and have:
Minimum four years relevant experience as a study manager (or similar) including continuous sponsor-CRO-interactions from a pharmaceutical company or CRO
A demonstrated ability to have managed global clinical studies, preferably within oncology or rare disease, during the entire study life cycle
Proven project management skills
Valid GCP training
Some experience from working with dedicated patient recruitment vendors
It is a merit if you have supply chain experience from sourcing of reference or comparator compounds to ensure IMP distribution, drug accountability and destruction
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
Take action and work under own direction
Are fluent in both spoken and written English and deliver effective written and oral communications to peers and management
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.
Travelling: some travelling will be required.
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, but no later than May 9th. 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
What we offer
At Ascelia Pharma, your skills, dedication, and engagement help us improve the lives of people living with cancer. We offer you an opportunity to be part of a fast-growing company with global reach, where engagement, dedication and results are met with opportunities for individual and professional development.
Join us on our journey to improve patients’ lives and build a global orphan oncology life science organization.
Ascelia Pharma currently has two drug candidates – Orviglance and Oncoral – in clinical development.
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