Freelance or permanent
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You?ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Here at INC Research/inVentiv Health we are currently recruiting for four programmers to be based on site at our global pharmaceutical partner. You will be an internal and external expert for complex data management and data quality considerations.
You will contribute to the technical strategy and delivery for global clinical project levels, including working with representatives from multiple project teams - clinical data standards, statistics and programming, and laboratory staff.
- Provide technical input to protocol and other plans at the development phase of a study, ensuring compliance with ICH-GCP and effective data collection practices.
- Coach and mentor colleagues with advanced programming tasks.
- Provide Input to the strategic delivery plan for data capture tools across the studies of a clinical development program.
- Provide input to the development of data capture tools for a clinical study, including the eCRF and ePRO.
- Ensures data programming procedure are of the highest quality and are audit ready.
- Lead role in developing strategic programming partnerships.
- Participates in due diligence activities and risk assessments with specific emphasis on the programming and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships.
- Lead role in the management of the data vendor deliverables and performance.
- Subject Matter Expert for the Data Quality Community bringing programming expertise, which would include expert input and the development, implementation and communication of programming control documents.
- Oversees CDISC/SDTM conversions with both internal and external partners.
The ideal candidate will need the following experience / skills to be considered:
- Knowledge of multiple programming languages
- Experience working with complex clinical data
- Experience with developing, validating, and maintaining clinical trials built in several EDC platforms
- Experience with evaluating electronic data collection systems
- Knowledge of the principles of quality, safety, risk management and compliance
- Solid understanding and experience of working with CDISC SDTM
- Experience with integrating multiple complex clinical study data throughout the entire study lifecycle, from protocol development through database lock.
- Experience of working with and overseeing the delivery of clinical data from external companies
- Experience interacting with project teams and laboratory staff and working in a matrix environment
- Effective written and verbal communication skills
- Ability to explain complex technical principles to non-technical staff.
There are many benefits available to employees of inVentiv. They include highly competitive compensation and benefits including: 25 days annual leave, sick pay, contributory pension, private healthcare, dental plan, life assurance, childcare vouchers, business travel insurance and personal accident policy management support / career counseling and bonuses!
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
Please be aware that due to the volume of applications received, only applicants being considered for this job opening will be contacted for further discussions
To find out more about our company and search and apply for other open jobs please visit our website *************************************
This job was originally posted as www.jobsite.co.uk/job/959356559