上海招聘

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.

About ExecuPharm

ExecuPharm, A PAREXEL Company, is a Global Functional Service Contract Research Organization, who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

ExecuPharm, with a core management team with extensive clinical operations experience, understands clinical trial challenges and how to solve clinical outsourcing, staffing, placement, technology and process needs.
 
21+ years of Experience Meeting Client Needs
16,250+ Global Clinical Operational Specialists In Network
80% of Recruiting Staff with >15 Years of Experience
Talent Acquisition, Deployment Rates, and Employee Retention above 90%
Management Staff with Tangible Industry Experience
Greater Than 95% Repeat Business
Average Turnaround Time of 14 Days To Deploy Project Team Resources

 
Global Capabilities

ExecuPharm’s clinical operations specialists are well versed in country and regional customs, business practices as well as regulatory and ethical restrictions and considerations. Having a resource that knows the culture, speak the language and is close in proximity to trial sites will aid in resolving any issues pertaining to the trial in a fast and efficient manner. ExecuPharm global locations are as follows:
 
King of Prussia, Pennsylvania, United States - North America
Mexico City, Mexico - North America
Buenos Aries, Argentina - South America
Chichester, United Kingdom - Europe
Bangalore, India - Asia
Shanghai, China - Asia
Tokyo, Japan - Asia


Mission

ExecuPharm was founded with the goal to support the requirements of clinical studies for all pharmaceutical and biotech's around the world. ExecuPharm’s expertise in the placement of staff and the conduct and management of all phases of clinical research and full drug development is attributed to our operational efficiencies, transparency in our partnerships and effective, responsive client service. These core values take the everyday burden and challenges of clinical studies off the clinical team, management and all stakeholders involved leading to faster, more cost efficient execution of studies.
 

Timeline

ExecuPharm has grown organically and strategically since 1995
1995: ExecuPharm founded
2005: Expansion of core services to include functional outsourcing (FSP) recruitment for specific functional areas in clinical research
2006: Awarded trial management personnel augmentation program
2007: Awarded FSP for all trial management activities
2008/2009: Further developed clinical operations department, adding multiple senior leaders from midsized and major pharmaceutical companies Significantly expanded corporate infrastructure to increase capabilities in IT, HR, QA and Recruiting
Expanded functional outsourcing services to include monitoring and site management

2012: Expanded services, with offices, into Europe and Latin America
2013: Expanded services, with offices, into Japan, China, and India
2014: Expanded services, with offices, into Mexico
2016: Acquired by PAREXEL