Local Trial Manager

Employer
Docs Global (Continental Europe)
Location
Romania
Salary
Competitive
Closing date
21 Sep 2020

View more

Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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Responsibilities:
• Acts as primary local/country contact for a trial.
• Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
• Leads and coordinates local trial team activities (CRAs and CTAs)
• Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.
• Reviews and approves Monitoring Visit Reports submitted by CRAs;
• Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.
• Implements any local criteria for site selection and recommends suitable sites for selection to participate in trial.
• Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
• Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints).
• Reviews and approves site and local vendor invoices as required
• Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for
Medical Affairs trials.

Requirements:
• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
• Study management experience ( LeadCRA or Study/Trial Manager)
• Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing the country language and English language.
• Good written and oral communication skill

If you have the right skills and experience, please email a copy of your up-to-date CV to: dariusz.sternlicht@docsglobal.com

#PMjob

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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