Clinical Project Manager - 10- 12 month contract
A challenging position in a dynamic company with competitive salary level commensurate with qualifications. Our Client is looking for a Clinical Project Manager with solid previous experience. The Clinical Project Manager will be to plan and manage clinical trials mainly in the vascular domain. You will oversee internal and external staff for the timely and quality implementation of trials. The Clinical Project Manager will oversee CRO and external vendor activities as well.
Reporting to the Director of Clinical Operations.
Responsibilities for the Clinical Project Manager :
- Contribute to the overall strategic planning of clinical development programs
- Interact with and integrate study plans from other departments into an overall clinical trial strategy
- Establish and update clinical project plan
- Develop and manage clinical project budget and timelines
- Prepare clinical protocols and amendments
- Develop or approve monitoring plans
- Approve the design, format and content of (e)CRFs, study guides and subject instructions
- Oversee activities associated with clinical site start-up
- Ensure appropriateness of forecast for investigational product and clinical supplies
- Develop and manage study and project budgets
- Manage Investigator Meetings
- Manage the overall Investigational product accountability and reconciliation process
- Ensure timely resolution of data queries and integration of vendor data
- Provide study-specific outsourcing specifications for RFPs
- Assist in preparation of Clinical Study Reports, Annual IND safety reports and ASRs
- Ensure compliance with TG's policies and procedures.
- Ensure all trials are carried out to the highest scientific and ethical standards
Profile
- University degree in medical sciences or equivalent through experience
- Minimum 6 years related experience in life sciences or medically related field, including 4 to 6 years clinical project management experience.
- Ability to use scientific and clinical knowledge to conceptualize study designs
- Effective written and oral skills especially with regard to scientific and clinical issues
- Proficiency in the preparation and review of clinical sections of study reports
- Experience with management of multinational clinical trials
- Knowledge of cardiovascular (thrombosis) therapeutic or product area
- Experience in preparation of clinical sections of CTA/MAA/IND/BLA
- Ability to anticipate and resolve problems
- Ability to work effectively in a team/matrix environment
Call John Frame on 01 2302400 for further information or email your CV to john@rftgroup.ie
No CV or details will be submitted to any potential client without prior knowledge, discussion and consent from "every" candidate.
The RFT Group: BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website: www.rftgroup.ie/ www.meddevicejobs.ie |
