Clinical Trials Project Manager |
Claudia@css-llc.net | 646.790.8355
Description: Manages the study preparation, conduct, and close out of clinical trials. May provide support on product approval applications.
1. Manages the conduct of Clinical Trials to ensure proper and timely completion, which may include the employment of a Contract Research Organization and contract, timeline and budget oversight. Ensures the training and monitoring of Clinical Investigator Site personnel. (40%) 2. Attends regularly scheduled project update meetings and evaluates and provides regular written feedback to staff/CRO on accuracy and completeness of work relating to Clinical Studies. (15%) 3. Prepares and ensures consistency, completeness and accuracy of clinical study documents and clinical trial master file. (15%) 4. For internal staff, manages performance, provides guidance on training, and development. (15%) 5. Manages and improves clinical trial processes, including benchmarking and leveraging across other Pharmaceutical companies. (10%) 6. Performs other related duties as assigned by management. (5%) Minimum education required for competent performance: Bachelor of Science or equivalent degree.
- Compiles information required for the clinical trial project quality plan including project timelines, resourcing, budget management and reconciliation, contract negotiation and finalization, and review and management of scopes of work and change orders.
- Develops monitoring plans and compiles data management plan, statistical analysis plan, and communication plan as part of the clinical trial project quality plan.
- In collaboration with the project team, responsible for preparing and finalizing key clinical documents which at minimum may include the clinical protocol, informed consent, case report form, and investigator’s brochure
- Develops request for proposals for clinical sites and CROs and other vendors as required
- Responsible for the identification and selection process for the clinical sites and Contract Research Organization (CRO).
- Supports the development of Master Services Agreements, Clinical Research Agreements, Scopes of Work and Change Orders.
- Manages and oversees CRO delegated responsibilities
- Responsible for reviewing final study reports
- Ensures that clinical trials are conducted meeting all applicable Regulations and Guidelines required to gain approval of investigational contact lenses.
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: Minimum of 8 years of experience in the Clinical Research of medical device/pharmaceutical regulated industry, with previous supervisory experience required. Must have a minimum of 2 years experience as a clinical research associate. Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP). Strategic & tactical Clinical and Business knowledge to gain approval and ensure maintenance of legal marketing status of all products. Strong communication, organizational and interpersonal skills. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.). Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met. Flexibility to provide innovative approaches to gain marketing approvals globally.
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