Clinical Research Manager with extensive experience in global phase III clinical studies
We are looking for a person with extensive experience in global phase III clinical studies and have experience in execution of global phase III trials.
As Clinical Research Manager at Cinclus Pharma, you will be part of a professional Global Clinical Operations team at the Head Quarters in Stockholm and you will report to the company´s Head of Clinical Operations.
The Clinical Research Manager position is primarily responsible for the execution and oversight of phase III clinical trials and lead of associated study team.
Responsibilities:
- Drive planning, execution and oversight of Cinclus sponsored clinical trials (phase III).
- Has a comprehensive overview of all Cinclus Pharma sponsored clinical study activities.
- Lead and document cross-functional study team and subsequent meetings from start-up through close out.
- Delegates study activities to project team as applicable. Identify process gaps, contribute on development of SOPs/working procedures as appropriate.
- Reports to Head of Clinical Operations and to members of the executive management team, if so requested, on overall clinical trial progress.
- Supports other functions with identification of potential vendors and review of vendor information, proposal and bid defense presentations.
- Active Management and oversight of CRO during the course of the study
- Review and approval selection of investigator site according to predefined criteria.
- Ensures the specific procedures, manuals and plans are developed, as needed, reviewed, approved and followed.
- Identifies and actions trend and metric issues for broader impact through root-cause analysis, when necessary, develops and directs and implements mitigation strategies, and ensures resolution.
- Responsible that clinical trials are delivered on time, on budget and to quality standards.
- Ensures project budget is in balance per contract, approves invoices and maintains budget forecast.
- Ensues that vendors effectively provide service within contracted time, budget and to quality standards.
- Work in partnership with other development functions such as regulatory, CMC and medical, as well as Service providers.
- Serve as resources of mentor to more junior team members on operational issues where appropriate.
Degree Requirements:
Scientific/healthcare related degree preferred
Experience Requirements:
5-10 years of clinical trial management, requirered experience in global phase III pivotal trials, most preferably from a smaller life science company/head quarters. Strong background in the operational aspects of clinical research trials, experience of working with oversight of outsourced sponsored clinical trials.
Key Competency Requirements:
- Independently manages assigned tasks, work with minimal supervision.
- With minimal guidance, makes decisions and action them appropriately.
- Adaptable and flexible-willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges.
- Critical thinking skills for problem solving.
- Ability to identify and interpret problems, recommend solutions.
- Ability to review, interpret, and analyze information to support discussions and make decisions.
- Identifies, develops and implements initiatives and best practices.
- Strong organizational skills, project management
- Collaborates with other departments, CRO teams.
- Strong leadership skills
- Effective team building and teamwork skills.
- Excellent communication skills (written and verbal) in English
- Excellent interpersonal skills
- Experience overseeing service providers
- Exceptional organizational and time management skills
Travel Required (nature and frequency), in office presence:
Extensive international travel can be required during different phases of the clinical trials. 2-3 days per week in the Cinclus Pharma office in Stockholm.
Contact and application
If you are interested, please apply to the role at hr@cincluspharma.com no later than 28th of April. But we will look at applications continuously. If you have questions, please contact Maria Löök Santesson, Head of Clinical Operations, maria.look@cincluspharma.com
Cinclus Pharma is a Swedish clinical-stage pharma company developing small molecules for the treatment of gastric acid-related diseases. Our lead candidate linaprazan glurate is being developed for the treatment of severe gastroesophageal reflux disease (GERD). Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments. The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025.