eCOA expert? We've got a great Senior PM/ Director role for rapidly growing team. If you have strong project management and leadership experience in clinical outcomes assessments and electronic patient recorded outcomes, we'd love to speak to you more about this.

Project related;

• Assume the role of primary contact regarding all project activities and related communications with the in-house team and the client sponsor company.
• You will work with the client from start-up to close-out across sponsor-specific protocols and company SOPs, putting in place best practises and project managing the work to meet and exceed goals
• Develop in agreement with the sponsor, the study specific user requirements
• Coordinate kick-off meeting with sponsor teams and internal teams prior to project initiation
• Follow up closely with development teams on the development and validation of the software taking study timelines into consideration and organize user acceptance testing in agreement with the sponsor requirements.
• Create protocol specific site and patient procedure manuals, processing instructions and training presentations.
• Organise translation of the patient and/or site procedure manuals (if applicable), taking timelines of Ethics Committees review meetings into consideration.
• Organise translation and validation of the screens available in the software (including all questionnaires, questions, answers and messages available for the subject and investigator to be developed in the software). Patient specific screens should be translated, taking timelines of Ethics Committees review meeting into consideration.
• Organise Psychometric Validation (if applicable) and questionnaire specific certification activities (if applicable).
• Develop eCOA portal functional requirements and interact with the team responsible for eCOA specific portal requirements set up. Include Software Development in the interaction when mapping files are concerned. Follow up on any user interface requests to access the eCOA portal.
• Interact with Logistics providers on study specific shipments and ensure shipments are done according to requested timelines by following up on this closely. Collaborate with Logistics regarding study specific equipment projections.
• Input and oversight of budgets including monthly invoices for assigned studies in collaboration with finance team. Collaborate with finance regarding billing issues related to assigned project. Collaborate with Business Development Operations on all study modifications that impact the budget and/or contract.
• Ensure that third party providers or the project team, as appropriate, are mainlining customer service as per project specifications
• Continuous improvement: Initiate study closeout/lessons learned meeting with sponsor and management upon study completion.

Company related;

• Work with quality management vendor to develop a quality management system 
• Work with existing quality teams and Quality Director to drive QMS implementation, particularly with respect to SDLC processes

Your skills:

• Proficient in all computer skills and basic office software: MS Word, MS Access, MS Excel, Project, Internet Explorer, Outlook, and PowerPoint.
• Previous eCOA experience essential
• Negotiation and Customer Service skills

Education:

• Project management experience preferred
• Strong presentation skills
• Minimum two year college degree in health/life sciences (or equivalent), 4 year preferred
• Two years' experience in clinical trial management preferred
• Excellent written and verbal communication skills.

Soft Skills:

• Strategic thinking
• Excellent communication skills
• Business acumen
• Solution based thinking
• Motivate others
• Foster teamwork
• Innovation
• Coach and develop others
• Ethical and acts with integrity
• Problem solving skill
• Results focused
• Interpersonal skills - build good relationships
• Friendly and positive attitude
• Drive and commitment
• Personal accountability - develop and manage oneself
• Adaptability and flexibility
• Teamwork and collaboration

Please contact gk@innovoassociates.com +447971666239 for more information.