Senior Study Start-Up Specialist

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Key Accountabilities:

SSU Coordination and Execution

• Coordinates guides andassistswith allstart upactivities prior to site activation including but not limited to: Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (EC) information meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies localize global ICF with country requirements. Local sample application and permit submission processes

• Maintains up to date knowledge ensuring adherence and compliance with local regulatory requirements and associated documentation

• Reviews analyzes and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation

• Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams

• Assistswith label preparation and approval (local label representative) for studies in collaboration with local regulatory department

• Tracks metrics and SSU timelines toidentifytrends and opportunities for improvement

Relationship management

• Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes government policies/laws via innovative approaches

• Maintains current and awareness of changes in startup processes across government hospital & industry & liaises with stakeholders to resolve any SSU issues

• Proactively responds to information survey requests by government/industry bodies

• Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtainaccurateand up to date information on clinical trial status and activities

• Maintains communication with local legal/regulatory/clinical operation to ensure input issoughtand all internal/external requirements are met

• Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics tracks & drives site activations by regular review and monitoring status of submissions/activations

• Collaborates with vendor management and procurement to provide input asrequiredinto vendor identification selection and Request for Information (RFI)/ Request for Proposal (RFP) process

• Liaises and shares best practices with other SSU within the region/organization

New Site Identification

• Assists with identification and tracking of new sites in collaboration with CSMs

• Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection

Contracts/Budget

• Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization

• Provides local fee structures and budgetary advice asrequiredand ensure compliance to Fair Market Value (FMV) in the country

• Collaborates with CSMs tomaintaindata to ensure FMV

• Liaises with management/CSMs to implement budget cost containment and implement contingencies asrequired

Compliance with Parexel standards

• Complies withrequired training curriculum

• Completes timesheets accurately asrequired

• Submits expense reports asrequired

• Updates CV asrequired

• Maintains a working knowledge of andcomply withParexel processes ICH-GCPs and other applicable requirements

Skills:

• Demonstrated competence in analysisplanningand problem solving.

• Excellent communications including the ability tostateopinions clearly ask questions seek clarification communicate facts objectively challenge whenappropriate and pursue issues to resolution.

• Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.

• Abilityto make effective decisions.

• Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.

• Demonstrated teamwork and ability to make an active contribution to team performance.

• Demonstrated computer literacy tousage of MS Office software web-based systems and databases.

• A flexible attitude with respect to work assignments and new learning.

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

• Willingness to work in a matrix environment and to value the importance of teamwork.

Knowledge and Experience:

• >3years of proved SSU experience in clinical trials experience in global company is preferred.

• Demonstrated knowledge and understanding of ICH-GCP the regulatory ethics and contractual requirements for starting clinical trials in China.

• Achieved a satisfactory level of technical functional and/or professional skill/knowledge in position related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge toaccomplishresults.

Education:

• University Degree or equivalent preferably in a medical/science-related field.