drjobs Central Monitoring Manager

Central Monitoring Manager

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1 Vacancy
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Job Location drjobs

Bucharest - Romania

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

  • Delivering on bestinclass central monitoring while driving financial/headcount efficiencies and increasing flexibility to rapidly respond to shifting business needs. 
  • Partnering with study teams to drive the implementation of the aggressive strategiesLine management of Central Monitors. 
  • Resourcing development of high performing teams contracting budgeting hiring performance reviews and leading talent development of staff including: linking the why and bigger picture elevating team to think more strategically creating a culture of challenging the status quo to drive efficiencies and innovation bringing ideas from outside of AbbVie inspiring the team and creating an inclusive and supportive environment.
  • Utilizes deep understanding of central monitoring and risk evaluation to support frontline staff and strength in influencing/partnering to build trust with Clinical Site Management Clinical Development Operations (CDO) and crossfunctional to ongoing development/advaneement/improvement of the RBQM systems providing requirements that will further enable nearreal time data analysis to ensure quality. 
  • Be an RBQM and champion across AbbVie supporting the of RBM processes as part of crossfunctional teams spanning the R&D portfolio (all therapeutic areas and phases of development). Advises when updates are needed. 
  • Support and contribute to the development embedding growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of programs and protocols.
  • Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.

Qualifications :

  • Bachelors degree in related field may include life sciences riskbased discipline.
  • Minimum of 6 years of clinically related experience or data trend analysis experience 4 years is required in study operations with 12 years people management experience (remote experience preferred).
  • Experience working in an RBQMmodel or similar experience with riskbased monitoring preferred. Experience/exposure to drug development operations risk management successful decisionmaking strategic in a fastpaced environment.
  •  Strong current indepth knowledge and understanding of appropriate therapeutic indications regulations and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management data management and regulatory operations).
  •  TA experience preferred in one of the following areas (Neuroscience Oncology Immunology Eye Care Medical Aesthetics Womens Healthcare GI). 
  • Strong analytical skills critical thinking functional expertise and good judgement and the ability to evaluate complex issues from multiple perspectives and drive SMART SURF decision making and timely outcomes. 
  • Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
  • Comfortable with use/operation of data analytics and visualization tools for oversight.
  • Excellent interpersonal skills with the ability to communicate persuasively and with clarity flexibility and adaptability to changing requirements resourcefulness and creativity. 
  • Demonstrated proactive and positive team player. 
  • Lead dynamic meetings and create engaging presentations. Respectfully provides transparent accurate and timely feedback to help direct reports improve performance. 
  • Remote role based in: Mexico Romani Poland UK or Ireland.


Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

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