Clinical Operations Manager Consultant South Plainfield, NJ
The Contract Senior Manager, Clinical Operations is responsible for providing the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across Therapeutic Areas (TAs). Works as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out. Manages relationships with external partners to ensure that timelines and deliverables are met. The incumbent works cross-functionally with internal departments and external resources on Clinical Research related issues. The Contract Senior Manager, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . Job Description: ESSENTIAL FUNCTIONS Participates in the development of the clinical strategy, trial design and protocol development including: Participates in the clinical research required for the study design (e.g. evaluating scientific literature, gathering investigator advice regarding current clinical practice(s) for the indication in question, etc.) Contributes to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as required. Participates in estimating clinical study timelines using appropriate project management tools. Manages PTC’s relationship with one or more assigned investigator sites and vendors including facilitating and participating in budget development, contract negotiations and expenditure oversight. Prepares investigator site lists and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content. Prepares investigator site lists and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content. Recommends strategies for and oversees the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency. Conducts periodic review of clinical trial data to ensure timely, consistent and accurate data flow. Presents project progress reports at internal team meetings and investigator meetings as required. Working with appropriate team members, collects files and maintains study-related documents. May assist in the interpretation of clinical study results in preparation for inclusion in Clinical Study Reports (CSRs) and regulatory submissions Compiles and reviews assigned portions of reports for submission to regulatory agencies and Institutional Review Boards (IRBs). Addresses and resolves questions from sites and trial monitors regarding trial conduct. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience. Bachelors degree in a scientific discipline and a minimum of 6 years of progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment OR equivalent education and/or experience. * Special knowledge or skills needed and/or licenses or certificates required. Comprehensive understanding of the drug developmental process. Thorough knowledge of clinical trial design and operations. Comprehensive knowledge of GCP and ICH guidelines. Ability to work both independently and collaboratively with internal and external team members. Excellent oral and written communication skills, including effective scientific writing and presentation skills. Proficiency with Microsoft Word and Excel. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. Prior involvement in IND and NDA submissions. Previous clinical monitoring experience. Medical writing experience or training. Experience with Microsoft Project and PowerPoint.