Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Clinical Trial Manager

Company: CTC Resourcing Solutions
Location: Yverdon-Les-Bains
Reference: 895312 -P
Closing Date: 28 Apr 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Manage timely delivery of all trial outputs from protocol development to final clinical study report (including archiving of the Trial Master File (TMF) within budget and with high quality standards, in adherence to internal SOPs, GCP and applicable regulatory guidelines.

Requirements:

Reference Number:         895312 -P

Type of placement:         Contract, 12-24+ months

Location:                        Yverdon-Les-Bains, Switzerland

 

 

Main Responsibilities:

 

  • Contribute to the development & review of study documentation such as the study  protocol, Informed Consent Form (ICF), study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements
  • Contribute to the development of regulatory documents, support the approval of submission packages to Health Authorities and ECs/IRBs and support the Regulatory Department in answering to Health Authority, IRB/IEC and/or DSMB questions/requirements
  • Supports identification and selection of ESPs, including establishment of scope of work and budget negotiation; ensure that related contracts comply with internal SOPs and legal requirements
  • Contribute to the development of specifications for Interactive Response Technology (IRT), Electronic Data Capture (EDC), and any study-related systems. Review ESP specifications in collaboration with SMT and ensure appropriate quality control of deliverables
  • Perform User Acceptance Testing (UAT)
  • Manages ESP’s oversight activities including monitoring and conduct co-monitoring visits to ensure data quality. Perform & document necessary quality checks. Perform ongoing ESP management, performance management and issue resolution
  • Check ESP invoices and ensure appropriate tracking and reconciliation 
  • Review forecasting of IMP and study supplies
  • Contribute to the planning & organization of Investigator meeting and CRA training(s), review related material and perform presentation(s) as appropriate.
  • Assist with the set up and maintenance of TMF for studies to ensure proper study documentation is maintained and archived in the TMF
  • Supports database lock activities oversight, to ensure timely data availability and coordinate study close out with ESPs as needed
  • Contribute to the development and follow-up of CAPA
  • Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP and applicable  regulatory guidelines

 

Qualifications and Experience

 

  • Master degree or equivalent university education/degree in life science or healthcare
  • Minimum of 4 years relevant experience in clinical development and clinical trial management, field monitoring experience is highly desired
  • Experience in managing international complex studies is an asset
  • Experience in selecting and managing external service providers
  • Thorough understanding of the drug development process
  • Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations
  • Solid experience in project management (including risk management and contingency planning)
  • Experience in executing a wide range of clinical trial activities across Phase I to Phase  IV studies (from initiation to clinical study report)
  • Good understanding of clinical trial budget
  • Strong written and verbal communication and presentation skills
  • Fluent in English & good command of French is mandatory
  • Good command of German is an asset
  • Pro-active and problem-solving attitude, strong prioritization skills

Apply for this job: Clinical Trial Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.