Local Site Activation lead
Proclinical is recruiting for a Local Site Activation Lead for a CRO located in Raleigh, NC. Successful candidate will oversee and manage the Site Activation Lifecycle at a regional level, support the Site Activation project team assigned during the start-up phase.
- Responsible to attend the KOM and cover all aspects related the Site Activation.
- Coordination of IRB/REB/RA submissions: will work alongside the GRM/LSAA Manager and Local Site Activation Associates to ensure submissions are performed according to internal and client expectations
- Coordination of Site Contracts & Budgets: will work alongside the Global Site Contract Manager and LSAA (Budget and Contract Specialization) to oversee the negotiations of contracts and budgets with sites and internal team according to the instructions agreed at the study level, and obtain client approval on budget increase requests if outside the allowed ranges of negotiations, support the creation of the Contract and Budget Plan (CTABP)
- Coordination of the Investigational Product Release Authorization (if applicable): will work alongside the Global Essential Document Team and Local Site Activation Staff to meet client expectations for first patient in at study/country level
- Plan realistic timelines for submissions and first site activation at study level, day to day management during study start-up
- Oversee the ICF process & translations of study required documents (patient materials)
- Participate in RFP budget reviews and proposal text development
- Present at internal and/or external meetings including Bid Defenses: prepare and deliver presentations in collaboration with relevant departments
- Responsible for appropriate issue escalation program to appropriate stakeholder(s)
- Serve as key client contact for assigned project(s), managing project milestones for start-up
- Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increased potential for repeat business
- Perform other duties as assigned by management
- Report directly to the COM/CRM
- Collaborate with Project Managers/Clinical Team Leads, Medical Affairs, Medical Writing, Data Management and Biostatistics, Quality Assurance, Business Development and Marketing Executives and staff
- Collaborate with Pharm-Olam project teams
- Support Services and Quality Assurance personnel
- Liaise with Sponsor scientific, medical, and corporate staff
- Liaise with sub-contractors
Skills and Requirements:
- 3 to 5 years clinical research experience on Site Activation related activities in the pharmaceutical or CRO industries
- Bachelor or higher university degree in life sciences, nursing or medical background preferred.
- Working knowledge of ICH Guidelines and GCP.
- Attention to detail with excellent oral and written communications skills.
- Able to thrive in a stressful environment and ability to work with changing priorities and to utilize resources effectively.
- Able to perform well as a team member.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to internal and external clients.
- Proficient computer skills with good working knowledge of a range of computer programs including CTMS systems.
- Ability to travel domestically and internationally as required
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Susan Chapman at (+1) 646-542-0158 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
€0.00 - €50000.00 per annum
A leading global contract research organisation is currently recruiting for a Site Contract Specialist at their office in the Netherlands.
A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a Senior Clinical Supply Manager to join their office in Shanghai.
Frankfurt am Main, Germany
A leading medical device company is currently recruiting for a Field Clinical Specialist at their office in Germany.