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.
Typically under the direction of a Director or COM/CRM, the Senior Manager, Local Site Activation is responsible and accountable for performing, (depending on the 4 grades of specialization identified below) all related site activation activities at a local level.
The Senior Manager, Local Site Activation can use different tools in CTMS during the Site Activation Lifecycle and 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.
The Senior Manager, Local Site Activation will provide leadership, mentorship, training and career development for assigned Site Activation Staff to assure the objectives of Pharm-Olam and the sponsor are met. The Manager, Local Site Activation will provide guidance to ensure that staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
This is a full-time, direct hire opportunity available in North America and can be remote based.We will also consider candidates interested in reduced hours. Candidates of interest should possess a strong background in clinical trial study startup / site activation management & leadership experience. #LI-Remote
Local Site Activation Specializations:
Regulatory Authority (RA) submission/approval activities - Key Responsibilities:
Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission/approval activities - Key Responsibilities:
Clinical Trial Agreement and Budget negotiation activities with sites - Key Responsibilities:
Essential Document collection activities: Submission of Essential Documents for an Investigator site and authorization for the shipment of Investigational Product to the site - Key Responsibilities:
Line Manager Key Responsibilities:
Please apply online at www.pharm-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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