Associate Director, Clinical Operations, Europe

Associate Director, Clinical Operations, Europe

Zogenix

Maidenhead, United Kingdom

Position Summary

The Associate Director, Clinical Operations will plan and coordinate the conduct of clinical trials including protocol development, site and vendor assessment and ensuring adherence to GCP and other applicable guidelines and regulations. In addition, the Associate Director, Clinical Operations will partner with cross-functional stakeholders in Clinical Development to develop systems and procedures to assure uniform operation of all projects in the department. This position is responsible Clinical Operations deliverables and for updating management on the status of the program.

Responsibilities

  • Provide oversight and leadership to the cross-functional study team(s);
  • Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports;
  • Manage study sites and train clinical site staff to ensure protocol and regulatory compliance;
  • Ensuring SOP and regulatory compliance of staff;
  • Responsible for CRO selection, development of RFPs, budget negotiations, and CRO management;
  • Responsible for clinical site budget and contract negotiation;
  • Participate and provide guidance for monitoring plans, coordinating study reports;
  • Coordinate and participate in investigator meetings;
  • Participate in monitoring visits, including Site Qualification and Site Initiation, as needed;
  • Mentor and develop junior team members;
  • Planning resources and tasks to meet corporate goals for timely initiation and completion of clinical studies;
  • Coordinating clinical site audit activities including pre-inspection training at clinical sites;
  • Establishing systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.;
  • Develop Clinical Trial Master Files according to applicable domestic and/or international regulations and internal SOPs;
  • Participating in other research related activities, as assigned.

Qualifications

  • Bachelor’s Degree in scientific discipline (Advanced degree preferred; Neuroscience training a bonus);
  • A minimum of 7+ years of industry experience, including at least 4 years of experience specifically in management of staff and managing CROs;
  • Knowledge of and competence in application of CFRs, GCPs and ICH Guidelines;
  • Written and verbal proficiency in multiple languages (English, French, Spanish, German) a plus.

Other Skills

  • Demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, Power Point) and computer skills;
  • Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences;
  • Strong team leadership experience and motivational skills;
  • Ability to problem solve and use good judgement;
  • Detail oriented;
  • Strong program management skills.

Special Working Conditions

  • Must be able to travel as required;
  • Must to able to work flexibly to enable collaboration with the US team and EU sites.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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