上海招聘

JOB SUMMARY:

Supports the management of the clinical study including project planning, budget adherence, and contract research organization/vendor management. Manages to the clinical operational plan and incorporates the study and scientific plan. Interacts with CROs/vendors and clinical sites to oversee execution of clinical trial. Participates in key activities such as data review and data cleaning on behalf of operations. Ensures compliance with good clinical practices and regulatory guidelines. Works with team to develop contingency plans for ensuring clinical trial timelines and key deliverables are met.

ACCOUNTABILITIES:

• Interact with CRO and vendors to ensure study plan remains on track. Review CRO operational plans (Project Management Plan, Clinical Monitoring Plan, TMF plan) and provide input into non-operational plans (DM plans, edit checks, safety monitoring plans).
• Support day-to-day study activities from start-up to close-out. Communicate United Neuroscience’s expectations regarding study execution to vendors, CRO and sites.
• Track key metrics for study progress and provide reports to clinical sub-team.
• Review monitoring reports, identify site issues and trends, and report to clinical study team and CRO.
• Other activities may include managing contracts, reviewing vendor proposals and budgets, and first-line review of vendor invoices.

REQUIREMENTS:

Education:

• B.S. degree in the Life Sciences

Experience:

• 3+ years of experience in clinical operations, including clinical trial management and site monitoring
• CNS experience preferred

Specialized knowledge, licenses, etc.:

• Strong knowledge of Good Clinical Practice preferred

Other skills/attributes:

• Strong written and verbal communication skills; English fluency required
• Proactive management skills

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