Trial Manager *** COUNTRY*** Officebased Madrid

Employer
Docs Global (Continental Europe)
Location
Spain
Salary
Competitive
Closing date
17 Sep 2020

View more

Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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? Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction withCTA (if applicable), SM and GTM. Implements any local criteria for site selection. Ensure consistent
conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit
report and country feasibility report. Recommends suitable sites for selection to participate in trial.
? Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select
final site list.
? Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and
Investigational Product documents at a country level or initiates development of these plans for a
single country trial.
? Leads and coordinates local trial team activities in compliance with GCO Standard Operating
Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning
activities to meet recruitment targets and to deliver high quality data on time and within study
budget. Including but not limited to: development of local trial specific procedures and tools,
recruitment planning, contingency and risk management, and budget forecasting.
? 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). Uses study tools and management reports available to analyze trial progress.
? 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.
? May submit requests for vendor services and may support vendor selection
? May lead negotiation of trial site contracts and budgets, with the assistant from a LTM II or III.
Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.
? Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country
investigator meeting.
? Conducts local trial team meetings and provides or facilitates SM training when needed (i.e.
implementation of study amendment-and changes in study related processes).
? Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends
across a trial project and escalates deviation issues to the GTM and FM as needed
? Reviews and approves site and local vendor invoices as required
? Works with SM to ensure CAPP is implemented for audits and inspection or any quality related
visits
? Complies with relevant training requirements.
? Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles
and responsibilities. May represent Global Clinical Operations on cross functional teams.
? Acts as primary local/country contact for a trial. 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.
? Actively contributes to process improvement.
? Internal Interfaces: Functional Manager, Partner with the CTAs, SMs, Quality & Compliance
Managers/Experts, Contracts and Grants associates, GTM, R&D study team (e.g., SRP), protocol
owners, data management and Medical Affairs (when applicable) to ensure overall trial coordination
and site management activities for assigned protocols.
? External Interfaces: Trial Site Personnel, external vendor representatives

#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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