global clinical operations program director, gothenburg.
- publicerad för 4 dagar sedan
- 10 dagar kvar att ansöka
ansvarsområden
- Typical Accountabilities and Responsibilities (delegated by Sr GPD)
- Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope
- quality
- budget
- time
- planning the resource and managing risk.
- Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
- Provide clinical operations expertise into the project (e.g. country selection
- feasibility
- operational input into design
- risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
- Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost
- timelines
- quality
- feasibility
- risk)
- Lead cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications
- maintenance support for regulatory interactions and reports and inspection readiness.
- Lead large or complex deliverables and the process to identify and solve or escalate operational issues. Drive delivery to plan through internal or external partners (alliance partners
- Clinical Research Organizations (CROs)
- vendors and Academic Research Organizations (AROs)).
- On behalf of CPT
- responsible for managing clinical plans (cost
- FTEs and timelines) in business reporting system
- such as PLANIT.
- Act as AZ point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
- Responsible for leadership and program management of non-drug project work as assigned
- e.g. cross functional improvement/change initiatives.
- Contribute to functional and cross-functional initiatives as Subject Matter Experts
- Mentor
- coach and support people development as appropriate.
- Actively participate in networking both within and outside the therapeutic area
- sharing best practises and lesson learnt.
- Be an early adopter for new ways of working and act as ambassadors for change
- driving the implementation and utilization of new initiatives.
- Typical Accountabilities and Responsibilities (delegated by Sr GPD)
kompetenser
- Pharmacovigilance
kvalifikationer
- Essential
- University degree (or equivalent)
- preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- At least 10 years’ experience from within the pharmaceutical industry or similar large multinational organization.
- Proven knowledge of project management tools and processes
- Proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Proven ability to learn by working in multiple phases
- TAs and/or different development situations.
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
- Ability to mentor
- develop and educate staff
- Project management certification
- Knowledge of process improvement methodology such as Lean Sigma/Change Management
- Regulatory submission experience
- Proven knowledge of clinical operations
- Experience with development and implementation of digital health initiatives in Clinical Studies
- it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
- Essential
utbildning
- Högskola/Universitet
jobba hos randstad life sciences
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