- Certified Scrum Master
- Clinical Trials
- Clinical Research
- Microsoft Office
- Certified Dental Assistant
The Clinical Study Manager (CSM) is responsible for coordinating all operational aspects of clinical trials including managing sites and vendors. The CSM will ensure that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials meets the requirements for Regulatory Authority approval, FDA post market surveillance activities or, in the case of post approval studies, publication requirements for peer reviewed journals.
With oversight from the Clinical Project Director, assures clinical trials are conducted in compliance with good clinical practices (GCPs) and in accordance with the FDA and/or EMEA regulations and ICH guidelines and meets quality standards defined by Merz North America, Inc. (MNA) SOPs.
Collaborates with Clinical Affairs and all other cross-functional departments within MNA in the overall study management of clinical trials.
Serves as a primary study team contact to manage the clinical operations of the trials and communicating team objectives to ensure quality and success.
Provides input for evaluating Request for Proposals (RFPs) and participates in selection of Clinical Research Organization(s)(CROs)/vendors.
Ensure that the clinical monitoring team deliverables are accurate, consistent with the overall study timelines and within budget.
Develop and maintain positive relationships with internal and external collaborators.
Collaborate on the development, review and approval of the per subject clinical grant and Clinical Trial Agreement (CTA) language. Oversee the management of the Confidential Disclosure Agreement (CDA) and CTA processes.
Oversee the development and review of study-specific tools, templates and documents (e.g. study plans, manuals, guidelines, and logs).
Contributes to the design and development of case report forms (CRFs), CRF guidelines/instructions and Data Management Plan.
Collaborate on the development and set-up of study systems (e.g. eDC, IVRS/IWRS, site payments and CTMS).
Responsible for developing and managing study and/or program budgets and timelines to ensure budgets and schedules are met.
Ensure monitor evaluation visits are performed as required per CRA Evaluation Plan.
Oversees the approval of regulatory documents for Clinical Trial Material (CTM) release authorization and site activation in collaboration with MNA Regulatory Affairs.
Coordinate the development, compilation, review and approval of informed consent forms (ICFs), clinical protocol/amendments proposals, study protocols and amendments.
In conjunction with biostatistics and data management colleagues, develop and review a data review plan. Conduct periodic review of study data (e.g. aggregate checks, tables, listing and figures).
Responsible for tracking and reporting operational metrics and to provide reports as required to upper management.
Responsible for the development and presentation of slides and training materials for various audiences (e.g. CROs, vendors, investigators, and study coordinators).
Education and Experience:
Certification in health related field or an Associate’s degree is required.
Minimum of 5 years clinical research experience is required.
Minimum of 2 years direct CRA experience or equivalent is required.
Knowledge, Skills and Abilities:
Excellent verbal, written communication skills and interpersonal and presentation skills are required.
Demonstrated experience using Microsoft Office applications to prepare charts, tables, forms, reports, and presentations. Experience with e-mail and calendar programs. Experience with IVRS and EDC systems a plus.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
Ability to develop tools and processes that increase measured efficiencies of the project.
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
Ability to travel up to 30%.
Associates or better.
5 years: Minimum of 5 years clinical research experience is required. Minimum of 2 years direct CRA experience or equivalent is required.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.