Clinical Study Manager – Phase I
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry.
The Clinical Study Manager is a critical position within the Operations team and is responsible for leading or supporting the planning, execution and reporting of clinical trials within budget and in accordance with corporate goals and objectives, applicable regulations and Standard Operating Procedures (SOPs). The role liaises with vendors and partners as needed, directing CRO management (when CROs are involved) and oversight of clinical activities. The Clinical Study Manager functions with moderate supervision, collaborating with inter- and intra-company resources to ensure quality performance and that project timelines and needs are being met.
- Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Evaluate and oversee the activities required to execute, conduct and complete large sized studies, managing to established timelines and corporate budgets
- Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Evaluate, select and manage clinical operation vendors to ensure adherence to scope of work, budget and study deliverables
- Evaluate, select and manage investigational sites to ensure adherence to scope of work, budget and study deliverables
- Function as Subject Matter Expert and primary liaison for site personnel and internal personnel in regards to study related topics and/or questions
- Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities
- Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)Develop, implement and ensure adherence to the monitoring plan for assigned studies
- Organize Investigator Meetings and any other internal/external meetings related to Clinical Trials and delivers presentations at these meetings
- Ensure the collection, accuracy and storage of study related documents
- Oversee study monitoring activities for assigned studies and personally conducts site visits as needed
- Ensure the review and tracking of monitoring reports for content, quality, adherence to GCP and timely submission
- The ideal candidate should have Phase 1/Clinical Pharmacology CSM experience
- BA/BS degree with 4 - 5 years clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial management experience
- Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions
- Working knowledge and experience with Word, PowerPoint and Excel
- Ability to travel occasionally (approximately 2-5 times per year)Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
- Ability to individually contribute results to a research and development effort
- Budget/finance experience on a project level and demonstrates a full understanding of project financials
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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