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Job Details

Clinical Project Manager - Belgium - Small Pharma - Huge Chances of Career Development to Director Level

Company: Barrington James Clinical
Location: Belgium
Reference: WP14/02CPMBEL
Closing Date: 14 Mar 17
Type: Permanent
Salary (£): Competitive
Benefits: Great Benefits

Job Summary:

This company is a game changer in the Clinical Project Manager world. They are looking to expand their resources for national and international projects. Are you a CPM with field experience? Talk to us without any obligation/commitment and see for yourself if we can help you build a better career path, improve your resume, get yourself a better life/work balance and increase your current compensation and benefits.

Requirements:

This company is a game changer in the Clinical Project Manager world. They are looking to expand their resources for national and international projects. Are you a CPM with field experience? Talk to us without any obligation/commitment and see for yourself if we can help you build a better career path, improve your resume, get yourself a better life/work balance and increase your current compensation and benefits.

They offer the assistance of an experienced team, as well as supporting you during your transition. Become a part of our expanding and internationally positioned company!

If you are interested in this challenging and varied position, then take the next step: Send us an English application stating your salary expectations and your earliest possible starting date.

 

RESPONSIBILITIES FOR THIS POSITION

Assume overall responsibility for the preparation of protocols and (electronic) Case Report Forms, patient informed consent, finalization of monitoring and data management options, Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, monitoring guidelines, protocols, site instructions for specimen collections, and study drug order forms
Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
Ensure that all aspects of GCP are complied
Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
Have responsibility for the financial management of the clinical trial program including budget planning and resource allocation.
Implement training program for clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.
Willing to invest in additional skills/knowledges indirectly related to clinical research: CMC, regulatory, pharmacovigilance, data management.

Complete and coordinate other regulatory documents (Pre-IND package, orphan disease designation, fast track) in collaboration with Medical Affairs departments

 

QUALIFICATIONS AND SKILLS

·      Bachelor or Master Degree in health or biologic science (BS/BA/ BScN or higher) is required; masters-level degree is preferred

 

·      A minimum of 3 year clinical study management experience in biopharmaceutical industry, including a minimum of 1 year as a clinical study lead / project manager is required; global clinical trial experience is highly preferred

 

·      Fluent (oral and written) in English

 

·      Experience in study project management and prior management of contracted resources/CROs is required; site monitoring and clinical quality compliance experience are preferred

 

·      Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge of other country regulatory requirements is preferred

 

·      Advanced computer skills including proficiency in Word and Excel are required and experience with PowerPoint is preferred;

 

·      Excellent communication skills (oral and written) and interpersonal skills are required

 

·      Strong operational management with attention to detail is required

 

·      Willingness to travel up to 20% of time including domestic and international travel is required

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Apply for this job: Clinical Project Manager - Belgium - Small Pharma - Huge Chances of Career Development to Director Level

Contact Information:

Address:  Head Office
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333

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