- Job Type: Full-Time
- Function: Life Sciences R&D/Engineering
- Industry: Healthcare
- Post Date: 01/22/2023
- Website: www.elligohealthresearch.com
- Company Address: 11612 Bee Cave Rd, Austin, Texas, 78738, US
- Salary Range: $50,000 - $150,000
About Elligo Health ResearchElligo Health Research is a healthcare-enabling research company. It provides physicians and their patients the opportunity to participate in clinical trials using health care informatics. The company offers a technology platform that provides multi therapeutic and geographic reach, enabling access to a range of physicians and patients.
This role has key objectives in the following two main areas:
- Implement the foundation of the global research site to grow Elligos ability to work with practices, sites globally
- Support the company’s growth, site success and innovative environment
(To perform this job satisfactorily, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.)
II. ESSENTIAL DUTIES
- Understanding of local / country and regional requirements for clinical trials
- Managing and steering External providers
- Relationship manager for country specific sites, providers which includes study pipeline planning
- Main contact for introduction of country represented sites directly to sponsor, CROs for possible clinical trial inclusion or indirectly in facilitating details that will enable another team member to introduce sites
- Nurture and convert study leads into study opportunities for our Irish network of sites or supply the business development team with sales points in order to do so
- Networking skills to represent the company to key local stakeholders
- Proactive issue monitoring and management
- Manages study start-up for all local clinical studies in own country. Is liaison between practices, internal Elligo stakeholders and sponsor, CRO
- Accountable for day-to-day activities of all aspects for the management of local and/or regional company sponsored studies, including study plans, timelines, resources, allocation, and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
- Manage External providers and/or independent consultants including CROs, Full-Service Provider teams, clinicians, etc.) when required by the project including and not limited to, oversight of the activities and coordination of project specific training, etc.
- Develop and monitor study budget and timelines
- Monitor work to ensure quality
- Ensures that trial status is accurate and up to date in Clinical Trial Management System
- Contribute to the planning and set-up of a study and provide planning parameters.
- Provide services and product expertise and/or oversight at the country level to external consultants, research site operations and staff, and/or flexible staff working on company sponsored clinical studies
- May be assigned one or more SME roles within global study functions (eg. Lead at the Country level in collaboration with the Program Clinical Delivery Lead)
- Coordinate within own region the study management for all local and regional clinical trials across all phases and therapy areas
- Support local and regional organizations in delivering local medical strategy across the portfolio within own region
- Work with CRO/external consultants in country / region to ensure local / regional trials are delivered within desired quality, timelines, and costs
- Main contact for HR for the recruitment and onboarding plan of regional site or study team members
- Collaborate with other team members to Improve current business practices analysis and strategy
- Main contact for international Key performance indicators meeting with leadership on a regular basis
III. KNOWLEDGE SKILLS AND ABILITIES REQUIRED
- BS/BA degree required
- 5+years of professional and project management experience in clinical research in CRO, research site, pharma or biotech company, including site management/oversight, clinical study planning and conduct.
- Three years international business experience
- Client relationship management
- Oncology TA experience desired. The ideal candidate will have experience leading oncology clinical trials and understand the methodologies, terminologies, and strategies that come with leading oncology studies.
- Outstanding communication and interpersonal abilities
- Ability to multitask in fast-past, high-pressure environment
- Exceptional written and verbal communication skills
IV. WORKING CONDITIONS
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.