START-UP LEAD - Singapore, Taiwan, Australia, Korea, Thailand, Philippines, New Zealand and India
Company: PRA Health Sciences
Location: Asia Pacific
Closing Date: 10 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits
An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Start-Up Lead and help realize your career potential.
Location: Singapore, Taiwan, Australia, Korea, Thailand, Philippines, New Zealand and India
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
For more information please see our website: www.prahs.com
The Start-up Lead (SUL) drives, manages and leads all aspects of Clinical Start-up activities at the country/region and project level to achieve successful activations of sites within timeline and according to budget. The SUL ensures all tasks meet Client and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable local regulations and requirements, and SOPs. The SUL proactively identifies, resolves/mitigates and escalates risks and/or issues. The SUL may manage multiple countries within the same study and/or multiple studies.
- Implements the project start-up methodology, to include project parameters, subject recruitment months and high-level study start-up activities/statuses) and documents the information within the Project Start-up Plan (PSP), CTMS and the Project Start-up Summary.
- Creates, maintains and facilitates Sponsor Approval of project documents related to study start-up, including the Essential Document Templates, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms.
- Creates, maintains and facilitates Client Approval of project status reports.
- Prepares and presents a project-specific overview to Clinical Operations, Investigator Grant Management and Global Regulatory Affairs staff regarding start up deliverables, timelines and processes.
- Oversees site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites are needed, and escalates delays, where applicable.
- Oversees the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In- House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions are developed, collected, reviewed and tracked according to the processes and timelines agreed upon on the project.
- Collaborates with the Global Regulatory Affairs Lead (GRAL) assigned to the project to ensure Ministry of Health (MoH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines.
- Collaborates with the GRAL and Clinical Team Manager (CTM) assigned to the project to ensure importation, exportation, insurance, labeling of Investigational Product (IP) and any other country requirements are met to ensure the timely activation of trial sites.
- Oversees Local Ethics Committee (IEC) and other local authority submissions and approvals for their country/region or the project as applicable.
- During Start-Up, works with GRAL/ LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where applicable).
- Performs Independent QC of Investigational Product Release packages and other documentation (i.e. Essential Documents and Informed Consent Forms) as determined by project specific process.
- Oversees system compliance from the IHCRAs and works with the GRAL and/or CTA Lead to address any system compliance issues from the LRAL/CA.
- Serves as primary liaison and primary point of escalation for project start-up issues for assigned countries.
- Conducts meetings to ensure all relevant team members are properly trained on start-up activities and kept current on timelines, clinical activities and contract and budget status.
- Uses available tools, including but not limited to the Critical Chain Methodology tool to establish site activation forecasts and ensures critical path activities are on target. Also oversees the completion of the system’s activities with the support of the CTM, GRAL and CTA Lead where necessary.
- Escalates risks to project start-up timelines for assigned countries and works with the CTM and/or Project Manager (PM) to mitigate those risks.
- For assigned countries, provides timely status reports on project start-up activities for internal and client teleconferences, and during monthly project review meetings with the SSU VP, Directors and Managers.
- With support from the CTM, ensures Time Entry Guidelines are adhered to by the IHCRA, determines worked hours and analyzes forecasted and worked activities to ensure adherence to contract and budget.
- Assesses and communicates impact of project scope on timeline changes and/or local resource requirements and escalates where necessary.
- Assists the CTM, CTA Lead, GRAL and/or PM with the forecast of units and hours and generic resourcing for IHCRA, LRAL and CA activities; determines worked units and hours and analyzes forecasted and worked activities to ensure adherence to contract and budget, as required.
- Facilitates the transition of study activities and status to the CTM and Clinical Research Associate (CRA) as sites/countries move out of Start-up and into Conduct.
- Any other duties deemed necessary to secure the success of PRA’s business.
- Resolves more complex study start-up issues by exercising advanced judgment when interacting with study sites or assisting assigned team members.
- May serve as Primary SUL when multiple SUL’s are assigned to large global studies or across programs with particular clients to ensure consistency across the project(s). When serving in the Primary SUL role, asks questions to understand and effectively communicate region/country specific nuances beyond the “standard” processes and procedures.
- Mentors, coaches, and trains multiple IHCRAs, SULs and other PRA staff where applicable.
- May participate in business development activities and answer strategic start up questions to other PRA operational areas.
- Recommends and implements enhancements to clinical systems to improve project start up delivery.
- Facilitates instructor led courses on behalf of Clinical Operations, as required.
Desired skills and qualifications:
- Read, write and speak fluent English; fluent in host country language required.
- Multi-country coordination experience or exposure to more than 1 country + cross cultural awareness.
- Typically 3 to 5 years of clinical research experience required or equivalent regulatory experience.
- Experience in managing and in meeting agreed on targets on clinical deliverables during the start-up phase of a project.
- Thorough knowledge of clinical start-up process and requirements required.
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed health-care professional (e.g., registered nurse) required.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.
If you have any questions please email firstname.lastname@example.org or call our recruitment department at +44 (0) 1189 5185 63.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.