Position Purpose:

The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.

Main Responsibilities and Accountabilities:

Study Start-up Coordination and Execution:

? Coordinate guide and assist with all start up activities prior to site activation, including but not limited to:

o Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements

o Ethics Committee information, meeting dates & costs

o Ethics applications & associated online systems

o Ethics & Governance submission processes

o Clinical Trial Health Authority application and regulatory submission process

o Contracts & Indemnity request process

o For global studies, localize global Informed Consent Form (ICF) with country requirements

? Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.

? Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.

? Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.

Study Start-Up Specialist (SSUS) JD: V2.0 Final Version dated: 24th June 2014 Supersedes V1.0 dated 13th Dec 2013

? Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.

? Track metrics and study start-up timelines to identify trends and opportunities for improvement.

Relationship management:

? Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches.

? Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues.

? Proactively respond to information survey requests by government / industry bodies.

? Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities.

? Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met.

? Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations.

? In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.

? Liaise and share best practices with other SSUS within the region/organization.

New Site Identification:

? Assist with identification and tracking of new sites in collaboration with CSMs.

Recruitment:

? Provide expertise and guidance to Global and/or Local Study Teams for identification, creation and implementation of specific recruitment/retention tactics & contingency planning.

? Initiate patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs.

? Develop innovative patient recruitment/retention practices and share concepts with vendors as needed.

? Provide justification/recommendation of site closure in collaboration with CSM.

? Provide reports to study teams on overall site performance as required.

Contracts/Budget:

? Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.

Study Start-Up Specialist (SSUS) JD: V2.0 Final Version dated: 24th June 2014 Supersedes V1.0 dated 13th Dec 2013

? Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country.

? Collaborate with CSMs to maintain data to ensure FMV.

? Liaise with management / CSMs to implement budget cost containment and implement contingencies as required.

Qualifications

? University Degree or Equivalent preferably in a medical/science-related field.

? Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.

? Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.

Skills, Experience and Competencies:

? Demonstrated competence in analysis, planning and problem solving.

? Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, 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

? Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork

? Able to make effective decisions, self-motivated, assertive, and displays initiative

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

? Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.

Other:

Availability to travel domestically and internationally if required.

上班地址：普陀区