Summary of Position :
The Senior DesignConsultant (DC) is responsible for delivering quality clinical trial design, developmentand consultancy to our pharmaceutical, biotechnology, medical device and CROcustomers.
They will provide support in terms of mentoring, training andconsulting to the DC team and to the customer whilst continuing to work withother departments to meet the customer requirements.
They are expected to takean active role in the review of design processes and in the roll-out of new andupgraded products.
Primary Responsibilities :
Workas a high profile member of the project team to develop and maintain excellentcustomer relationships
Gatherand interpret customer requirements and using Oracle Health Science’s trialdesign software, translate these into design specifications
Workwith the study team and sales department to scope required effort, definetimelines and plan resourcing
Provideadvice and implement study design related changes throughout the triallife-cycle
Demonstratean ability and willingness to travel to customer sites, predominantly inEurope, up to 40%
Providetraining and mentoring support to new team members, including independentreview of design specifications
Supportsales department in demonstrations and other pre-sales activities
Providementoring support to customers / partners
Reviewnew product requirement documentation and functional specifications to assessimpact on the trial design team
Contributeto new product identification, roll-out and implementation
Workwith the customer and Technical Consultants to generate customised data export specifications to map data to specific customerrequirements
Workwith the customer and Technical Consultants to generate integration specifications to specific customer requirements
Participatein the recruitment and selection process, including giving input intoand conducting interviews
Take a lead role in the modificationof work instructions and design processes to continually improve efficiency,quality and consistency
QC ofdesign specifications (eCRF, edit check and eHelp) as required by the DC team
Participate in design consultancy activities, including the developmentand delivery of presentations, workshops, training and other customer serviceofferings
Act as a shared knowledge resource for other DCs and other departments
Competency Requirements :
A goodunderstanding of the clinical trial process, preferably from a clinical datamanagement perspective
Ableto review and interpret clinical trial documentation e.g. protocols
Abilityto work effectively in a fast-paced team and / or independent environment
Afamiliarity with database structures and the logic used in programminglanguages
Excellenteye for detail
Excellent communication skills including presenting, coaching, facilitatingdiscussions and brainstorming
Innovativeand proactive approach to the design process
Abilityto manage and organise multiple tasks and project deliverables
Comprehensiveknowledge of internet technology and MS Office applications, to include Word, Excel and PowerPoint
Ademonstrated ability for training, including coaching and mentoring skills
Comprehensive knowledge of departmental and company processes andprocedures
Qualifications and Experience Required :
Degreein life science, nursing qualification and / or relevant experience
Previousexperience within the clinical trials industry, ideally in clinical datamanagement
Thoroughknowledge and understanding of ICH-GCP and other applicable regulationsassociated with clinical trial data handling, preferably including 21 CFR Part11
Experienceof requirements gathering, design and specification development of CRFs, editchecks and site queries preferably within a CRO environment
Current,full driving licence
Previousexperience with InForm and Oracle Health Science’s trial design software in acustomer facing role
Experienceof one to one mentoring and group training
Experienceof process review and documentation of processes
Experienceof designing Phase I to IV trials with a range of differing trial design typesand complexities
Detailed Description and Job Requirements
Intermediate consulting position operating independently with some assistance and guidance to provide quality work products to a project team or customer that comply with Oracle methodologies and practices.
Performs standard duties and tasks with some variation to implement Oracle products and technology to meet customer specifications.
Standard assignments are accomplished without assistance by exercising independent judgment, within defined policies and processes, to deliver functional and technical solutions on moderately complex customer engagements.
2-5 years of overall experience in relevant functional or technical roles. Undergraduate degree or equivalent experience.
Product or technical expertise relevant to practice focus. Ability to communicate effectively and build rapport with team members and clients.
Ability to travel as needed.
As part of Oracle's employment process candidates will be required to complete a pre-employment screening process, prior to an offer being made.
This will involve identity and employment verification, salaryverification, professional references, education verification and professional qualifications and memberships (if applicable).
Romania, RO-RO,Romania-Iasi, Hungary, RO-RO,Romania-Bucharest, District 2, HU-Hungary, RO-Romania, RO-RO,Romania-Bucharest