Lilly Consultant Trial Capabilities in Cork, Ireland
Type of Employment:
Full-Time Employment - FTE
Therapeutic area leadership through owning TC strategy to execute on clinical trial plans
Influence global trial strategy to drive regional improved site activation cycle times
Accountable for meeting and exceeding goals for clinical trial initiation for development programs.
Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners.
Accountable for prioritisation of work to meet portfolio needs.
Ensure flexilbility of resources across trial capabilities teams and geographies.
Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements and external environment
Develop and deliver strategies to improve customer experience.
Monitor execution of strategy and performance of global processes by local and/ or regional teams via metrics and controls.
Ensure inspection readiness through a complete, accurate and readily available Trial Master File
Act as system/process owner for any relevant technologies/regional processes and represent the region in global initiatives
Manage relationship(s) and influence processes with any relevant global third party technology or services and CROs
Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred
Understanding of the overall clinical development paradigm and the importance of efficient site initiation
Experience working with regional or global mind-set
Strong leadership skills and ability to influence others and lead across the business
Project management processes and skills
Appreciation of / experience in compliance-driven environment
Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
Effective communication, negotiation, and problem solving skills
Self-management and organizational skills
Effective problem-solving, business acumen and analytical skills to evaluate and resolve complex operational and / or technical issues
Language capabilities an advantage
Own TC hub process map and build capabilities through the development and improvement of processes, tools and training and partnering with Clinical System and Supplies Planning (CSSP) to leverage technology to increase efficiency of clinical trial resources.
Identify and Lead shared learning across the clinical capabilities organization and with other functional groups within the CDDA and Medical
Lead and influence a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
Partner and influence other CDDA or GBS functions/leadership to drive efficient clinical development processes and procedures
Mentor others to deliver on strategies.
SME for global and regional TC processes, driving adoption of best practices
The Trial Capabilities Consultant leads the clinical trial capabilities in support of clinical development. The Consultant is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. This includes submission of documents to regulatory authorities and Ethics Review Boards, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), assist in budget and contract negotiation. The Consultant is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.
The Consultant provides leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on driving efficiency across the regional hub to achieve goals and objectives. This includes owning the regional processes and strategies aligned with CDDA funcntions, representing trial capabilities globally, and driving continuous improvement. The consultant will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File.
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals. Today more than 500 are based at our Global Business Solutions centre in Little Island, Cork. There we boast a vibrant workforce made up of over 35 nationalities, speaking over 27 languages.
Established in 2010 to gain efficiencies in Finance GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions.
This, along with the current physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! The new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings.
Our benefits package includes healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, educational assistance, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.
At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations.
Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.
“We see Cork as an integral part of our productivity agenda. If you are excited by new opportunity and new scope, you are working at the right place.” – Dave Ricks, CEO Lilly
We are excited now to add another capability to the existing GBS team. The Clinical Trial Capabilities Team will focus on clinical research and, in particular, clinical study start-up activities across the EU and other regions, e.g. Middle East, Africa and Russia. The Clinical Trial Capabilities Centre will allow us to provide an unparalleled clinical trial experience for investigators and patients and ultimately achieve Lilly’s goal of speeding innovation and bringing our medicines to patients who need them.
If you want to contribute to this goal for our patients please apply to one of our new roles today. All current open positions are permanent roles
Region: Europe; Middle East; Africa
Req Id: 52052BR