Manager/ Senior Manager Clinical Systems Specialist, Clinical Operations

BeiGene Switzerland GmbH (Basel, Schweiz) Vor 5 Tagen veröffentlicht

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

NO AGENCIES

MANDATORY EXPERIENCE - Pharmaceutical/Biotech/CRO industry

Preferred location: Basel, Switzerland

Purpose of Job

  • Participates in the relevant China and/or global Systems Implementation departmental teams
  • Accountable to, and partner with Clinical Study Teams (CST)and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials
  • Provides clinical study systems implementation, UAT, process and related tools expertise. Clinical systems mentioned here refer to but not limited to IRT, ePRO, CTMS, etc.

Major Responsibilities

  • Serve as first line of contact for triaging all CST support and service requests for each clinical study, and ensure prompt resolution of system issues and provide timely and accurate responses to customers Works with Clinical Study Teams(CST) and other functions to gather, analyze, and synthesize study specifications, goals and objectives and translate these into study systems, process and related tool requirements.  Including required resources, such as any required budget, IT or external vendor partner support, milestones and key deliverables
  • Develops and maintains standard project timelines for study specific systems set-up, UAT and maintenance Where applicable, assists partners and stakeholders in planning UAT activities and advising others regarding practices, processes, policies, procedures, protocols, timing and other requirements for timely and effective UAT
  • Provides Good Clinical Practice (GCP) and Good Documentation Practices (GDP) guidance to CSTs and potentially others
  • Where applicable, deliver system related training to CST and/or form the training process in compliance with GCP
  • Completes other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, company SOPs and other guidelines

Qualification

  • Bachelor’s degree required
  • Advanced experience in supporting information systems, and clinical systems experience is a plus
  • Advanced knowledge and experience working with clinical trials management and/or clinical data management processes is preferred
  • Project management skills are required, PM Certification, such as PMP is a plus
  • Previous experience in development, deployment and/or maintenance of information systems (especially EDC, IRT, ePRO, CTMS or Clinical Supply systems) in the pharmaceutical, biotechnology or related industry; to include user acceptance testing for computer systems
  • Broad understanding of international regulations, processes and issues in drug development.  Includes sound understanding of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), and related systems that support clinical trials and clinical operations processes
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
  • Fluent English and other language skills as needed

Abilities

  • Outstanding attention-to-detail
  • Comfortable working in a fast-paced, dynamic environment
  • Excellent time management & organizational skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
  • Good interpersonal, communication and influencing skills; can influence without authority
  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel (<20%)

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Manager/ Senior Manager Clinical Systems Specialist, Clinical Operations

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