Global Study Manager

1 week ago

bangalore, India Excelya Full time

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.


To learn more about us, visit

The Position:

We are seeking to hire a Clinical Global Study Manager for a sponsor specific position in a global pharmaceutical company. Within the clinical operations department, you will act as Global Study Manager on the following missions:


What we Offer:

Competitive remuneration package

Mobile phone/internet

Laptop

Medical private insurance

Food vouchers


Essential Functions:

  • Overall coordination and supervision of the study, including all activities (Clinical, monitoring, data management, statistics, medical writing, pharmacovigilance, study treatments, etc.).
  • Control study deadlines and monitor important study deliverables
  • Coordinate and participate with other team members in meetings related to the study.
  • Supervise the activities and monitoring of study monitoring by controlling quality (frequency of monitoring visits, lists of deviations, review of a sample of monitoring reports, status of the e-CRF, co-monitoring of visits etc.)
  • Coordination of the clinical study in its entirety: drafting of the protocol, responses to calls for tenders, supplier management, selection of CROs.


Education and Experience

  • Holder of a PhD, Master or BA/BS/BSc relevant degree or qualified nurse (RN)
  • Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)


Preferred Qualifications

  • Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
  • Experience in a project leadership role
  • Experience working with or for Functional Service Provider or Contract Research Organizations
  • Supervisory Experience
  • Knowledge of or work experience with a biopharmaceutical GRDCA or QC department


Knowledge:

  • Familiarity with advanced concepts of clinical research
  • Extensive knowledge of ICH/GCP regulations and guidelines
  • Strong knowledge of clinical trial operations
  • Computer and system operation skills
  • Relevant therapeutic area education and training


Language:

  • Business English fluency
  • Excellent/Native level knowledge of local language


Competencies :

  • Excellence in relationship building
  • Ability to lead and influence in a positive manner
  • Strong interpersonal & Leadership skills
  • Excellent organizational and planning skills
  • Excellent oral and written communication
  • Attention to quality and detail
  • Ability to identify and resolve problems
  • Ability for critical thinking and thinking out of the box

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