Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. #LI-Remote This is Important Work
Typically under the direction of a COM/CRM, the Local Site Activation Lead, oversees and manages the Site Activation Lifecycle at a regional level, supporting the Site Activation project team assigned during the start up phase
The Local Site Activation Lead will be responsible and accountable to keep the Site Activation Milestones on track during the course of the study(s), therereby ensuring that expectations are met while identifying and mitigating the start up risks. Your Role
The Key responsibilities defined below may be carried out independently or with the oversight of a Global Site Activation Manager/Sr. Manager at project level where required.
- 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 on the development of study specific plans for start-up (Clinical Trial Agreement and Budget Plan, Regulatory and Ethics Submission Plan, Investigational Product Authorization and Release Plan): implement and monitor progress against project plans and revise as necessary
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
- Prepare and actively participate in internal Project Review Meetings in absence of a GSAM
- Review Site Activation budget and track out of scope budget acitivites.
- Ensure Change Orders are requested as needed and at risk work has Senior Management approval.
- 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
Required Education and Qualifications
- 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
- Bachelor or higher university degree in life sciences, nursing or medical background.
- 3 to 5 years clinical research experience on Site Activation related activities in the pharmaceutical or CRO industries
- 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.
- Computer skills with good working knowledge of a range of computer programs including CTMS systems.
- Ability to travel domestically and internationally as required
Please apply online at #removed#-olam.com/careers
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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