Reporting to the Director, Clinical Operations, the Study Manager is responsible for operational activities, and leadership for the execution of the assigned clinical studies (Phases I-IV) under supervision. The person in this role will manage day-to-day activities of all aspects for the management of clinical studies, including study plans, timelines, resources, allocation and management of product (re-)supply, problem identification and resolution, status reports and budget with supervision, as needed. Additionally, this role is responsible for managing operations planning, and execution of clinical studies, leveraging internal and external resources like CRO/vendors, expertise, and knowledge; managing site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of study participants with secure randomization processes (if required) and closeout; and overseeing CRO/vendor selection, budget and contract negotiation and proper supervision of performance for all activities for assigned studies under supervision.
Responsibilities:
Manage operations planning, and execution of clinical studies, leveraging internal and external resources like CRO/vendors, expertise, and knowledge.
Ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency
Manages site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of study participants with secure randomization processes (if required) and closeout.
Assists in the preparation, review and submission of regulatory documents for study approvals.
Oversees CRO/vendor selection, budget and contract negotiation and proper supervision of performance for all activities for assigned studies under supervision.
Monitors study budget and timelines, in managing budgetary spend of the clinical trial study and communicating with the head of Clinical Operations and Project Leader under supervision
Negotiates clinical trial agreements and budgets, managing site payments with relevant project team and Legal team members.
Manages day-to-day activities of all aspects for the management of clinical studies, including study plans, timelines, resources, allocation and management of product (re-)supply, problem identification and resolution, status reports and budget under supervision.
Manages site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of trial participants with secure randomization processes (if required) and closeout
Creates and/or reviews the study plans, specification documents, materials, and tools.
Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations. Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.
In conjunction with the CRO, identifies required study specific training of the clinical staff, ensuring understanding of the drug development process and knowledge of international standards (GCP/ICH), the requirements and compliance with the appropriate health authorities (FDA/EMEA), and the application of the aforementioned to the entire study.
Assists in review of protocol and case report forms (CRFs), applicable SOPs, team communications, computer software/IT training, the importance of pharmacovigilance and adverse event reporting so that all team members are not only informed, but also aligned.
Provides written/verbal communication to those involved in the clinical study, which includes but is not limited to study participants and internal/external team members under supervision
Establishes collaborative working relationships with cross-functional team members and service providers
Provides oversight of CROs in the execution of (a) clinical study(ies) and interactions with CRO's to establish an agreed up clinical study platform and in partnering with CRO in audit responses and addressing quality issues under supervision.
Requirements / Qualifications:
Bachelor of Science or Bachelor of Arts degree, or the equivalent in work experience, preferably in life sciences.
2+ years of clinical study management experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organization (CRO) or a clinical research site.
3+ years of Clinical Operations work experience. Proficiency in using CTMS and EDC systems.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
Knowledge of the Pharmaceutical Industry Clinical study process (clinical study conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
Possesses effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize
Mathematical capabilities required for Performance projection and Budget management
Ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high-quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.
Able to interact effectively at all levels within the organization, as well as with external partners and clients.
Strong listener, as well as a communicator. Able to effectively present information in a clear and concise manner, and effectively answering questions of internal and external parties
This role may require the incumbent to travel, which will be primarily domestic, Travel will be scheduled based upon the needs of the business, up to 10% of the time.