Manager, Clinical Operations
Bristol-Myers Squibb
Madrid, Spain
hace 1 día

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb Regional Clinical Operations (RCO) Spain & Portugal team is looking for a professional to lead our teams in R&D regional organization, responsible for the execution of phase I-IV clinical studies in the region.

Purpose / Objective of the job

To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO COUNTRY or COUNTRY CLUSTER

Key Responsibilities and Major Duties

  • Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and / or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities
  • Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
  • Anticipates resource needs and provides workload evaluations and task assignments
  • Allocates and assign study resources in alignment with R&D and local research goals and priorities.
  • Supervises clinical trial execution at country level including supervising study metrics and team performance
  • Approves study fee funds and payments based on grant of authority
  • May propose and / or validate country study targets
  • May support Health Authority inspection and pre-inspection activities
  • May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
  • Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
  • Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met
  • Together with the RCO management tracks and manages performance metrics for Clinical Operations staff
  • Anticipates and initiates action in response to multiple / changing demands and project priorities placed on Clinical Operations Unit
  • Point of Contact for FSP staff within the country
  • Managing the hiring, performance management and succession planning of staff
  • Performing general and human resource administrative functions
  • Participation in performance calibration and talent review meetings
  • Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
  • When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
  • Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and / or Heath Authorities as needed
  • Manage partnerships with critical accounts / sites
  • Disclaimer : The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

    Qualifications and Requirements

  • Bachelors or Masters Degree within life sciences or equivalent
  • Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
  • Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
  • Demonstrated ability to drive project related activities
  • Previous supervisory and / or leadership experience (i.e. participation in task force, initiative or cross functional team)
  • Previous resource allocation experience preferred
  • Experience mentoring and providing feedback to others
  • In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
  • In depth knowledge and understanding of clinical research processes, regulations and methodology
  • Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
  • Demonstrated organizational and planning skills and independent decision-making ability
  • Strong organization and time management skills and ability to effectively manage multiple competing priorities
  • Outstanding interpersonal, oral and written communication skills to influence, inform or guide others
  • Good verbal and written communication skills (both in English and local language).
  • Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to gender identity, race, color, religion, sexual orientation, national origin or disability.

    We are proud of being recognized in Spain as a Top Employer company 2019 with certified excellence in employee conditions and also of being listed as one of the 100 best companies to work for in Spain in 2018 by Actualidad Económica magazine.

    Come, and join BMS now!

    Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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