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Clinical Study Manager
vor 3 Wochen
**Role & Function**
The Clinical Study Manager leads and manages the cross-functional clinical study team, and ensures delivery of clinical study activities to agreed timelines, budget and quality.
**Key Responsibilities**
Lead and manage the cross-functional clinical study team and supervise that the objectives and responsibilities within the team are fulfilled
Ensure knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with investigators, study site personnel, External Service Providers (ESPs), other external parties and Sobi affiliates
Ensure delivery of all clinical study activities in accordance to agreed timelines, budget and quality
Lead and manage appointed ESPs and follow-up on ESP performance to ensure Sponsor oversight and manage ESP contracts, amendments and change orders
Manage the risks to critical data and processes and the implementation of appropriate risk control measures
Ensure management and reporting of protocol deviations, suspected serious breaches and other GCP non-conformances
**Qualifications**
University degree in Life/Health Sciences
A minimum of 5 years' experience of planning, conducting and reporting multicenter, international clinical studies
Extensive knowledge of all aspects of the clinical study process
Experience of managing ESPs
Demonstrated ability to lead multi-disciplinary teams including team building, negotiation and conflict resolution
**Personal attributes**
A high level of proactivity, commitment and energy
Strong leadership and coaching skills
Strong interpersonal skills with communicative and flexible attitude
Excellent problem-solving skills and a “can do attitude”
Strong individual initiative, organization skills and multi-tasking abilities
Strong customer-oriented mindset
Excellent written and oral communication skills in English
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
**Location**
Basel, Switzerland
**Reporting to**
Head of Clinical Study Management
**Why Join Us?**
We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
**Sobi Culture**
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.
This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.
Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
**An Equal Opportunity Employer**
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