Address
Form of workTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an immediate opening in our Monmouth Junction, NJ location for a Clinical Trial Manager (CTM).
The CTM is responsible for cross functional collaboration with other functional leads to develop, implement and support clinical study processes and procedures to ensure timely execution of quality Clinical Trials. The CTM liaises closely, and is a key study contact, with internal and external stakeholders (i.e., internal cross-functional teams, Clinical Research Organizations (CROs) and vendors.
• Develops and coordinates Clinical Trial and operational activities and manages execution to ensure completion according to project timeline and budget
• Coordinates and leads cross-functional project team meetings including representatives from multiple internal departments (i.e., Medical Affairs, Regulatory Affairs, Data Management, etc.)
• Reviews/finalizes study protocols, informed consent forms, amendments, case report forms (CRFs) and clinical study reports (CSRs)
• Coordinates qualification and selection of clinical sites, plans and presents at Investigator Meetings, develops additional site training materials, as needed; Develops Clinical Trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including but not limited to: project communication, monitoring, recruitment and risk mitigation plans; Responsible for ensuring development and updating of cost estimates at study and project level
• Coordinates vendor selection process including, but not limited to: input and review of draft Request For Proposal (RFP), review of returned RFPs, bid defense meetings, audits, final vendor selection activities, etc.; Manages vendor and CRO activities and tracks internal and external (CRO/vendor) project deliverables to ensure timeline and budget
• Establishes and maintains regular contact with investigators, vendors and study site staff to ensure current Good Clinical Practice (cGCP)/International Council for Harmonisation (ICH)/protocol and company Standard Operating Procedures (SOPs) are compliant
• Performs sponsor oversight of monitoring visits including site qualification, study site initiation, routine monitoring and study site closure visits including review of monitoring reports and follow-up letters; Responsible for ensuring development and updating of cost estimates at study and project level
• Develops agenda and manages planning and execution of Investigator Meetings; Handles meeting vendor contracting and management, coordinates meeting agenda development, content development and delivery of operational (non-Clinical Science) presentations and training materials; Manages meeting execution and documentation and ensures input from key stakeholders
• Develops subject recruitment/retention strategy and related initiatives
• Oversees maintenance and quality review of study Trial Master Files (TMFs); Develops and maintains tools for study deliverables management (i.e., timelines, study plans, etc.)
Requirements
REQUIREMENTS
Bachelors degree in (para)medical, pharmaceutical or science related field and minimum 4 years in-house clinical (Clinical Research Associate (CRA), Clinical Trial Associate (CTA) or related experience) in positions of increasing technical and operational responsibility (at least 2 of those years must include managing all aspect of Clinical Trials independently).
Special knowledge or skills needed and/or licenses or certificates required
• Current, working knowledge of Code of Federal Regulations (CFR) Title 21 Part 314.80, Part 314.81, Part 314.98 and related FDA guidance
• Hands on experience managing multiple Clinical Trials (of varying phases) simultaneously
• Experience developing and presenting logical solutions to complex problems proactively prior to study impact
• Thorough working knowledge and understanding of cGCPs, ICH and regulatory guidelines and their implementation in Clinical Trials
• Proficiency with Microsoft Office including MS Project
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid
Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an immediate opening in our Monmouth Junction, NJ location for a Clinical Trial Manager (CTM).
The CTM is responsible for cross functional collaboration with other functional leads to develop, implement and support clinical study processes and procedures to ensure timely execution of quality Clinical Trials. The CTM liaises closely, and is a key study contact, with internal and external stakeholders (i.e., internal cross-functional teams, Clinical Research Organizations (CROs) and vendors.
• Develops and coordinates Clinical Trial and operational activities and manages execution to ensure completion according to project timeline and budget
• Coordinates and leads cross-functional project team meetings including representatives from multiple internal departments (i.e., Medical Affairs, Regulatory Affairs, Data Management, etc.)
• Reviews/finalizes study protocols, informed consent forms, amendments, case report forms (CRFs) and clinical study reports (CSRs)
• Coordinates qualification and selection of clinical sites, plans and presents at Investigator Meetings, develops additional site training materials, as needed; Develops Clinical Trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including but not limited to: project communication, monitoring, recruitment and risk mitigation plans; Responsible for ensuring development and updating of cost estimates at study and project level
• Coordinates vendor selection process including, but not limited to: input and review of draft Request For Proposal (RFP), review of returned RFPs, bid defense meetings, audits, final vendor selection activities, etc.; Manages vendor and CRO activities and tracks internal and external (CRO/vendor) project deliverables to ensure timeline and budget
• Establishes and maintains regular contact with investigators, vendors and study site staff to ensure current Good Clinical Practice (cGCP)/International Council for Harmonisation (ICH)/protocol and company Standard Operating Procedures (SOPs) are compliant
• Performs sponsor oversight of monitoring visits including site qualification, study site initiation, routine monitoring and study site closure visits including review of monitoring reports and follow-up letters; Responsible for ensuring development and updating of cost estimates at study and project level
• Develops agenda and manages planning and execution of Investigator Meetings; Handles meeting vendor contracting and management, coordinates meeting agenda development, content development and delivery of operational (non-Clinical Science) presentations and training materials; Manages meeting execution and documentation and ensures input from key stakeholders
• Develops subject recruitment/retention strategy and related initiatives
• Oversees maintenance and quality review of study Trial Master Files (TMFs); Develops and maintains tools for study deliverables management (i.e., timelines, study plans, etc.)
Requirements
REQUIREMENTS
Bachelors degree in (para)medical, pharmaceutical or science related field and minimum 4 years in-house clinical (Clinical Research Associate (CRA), Clinical Trial Associate (CTA) or related experience) in positions of increasing technical and operational responsibility (at least 2 of those years must include managing all aspect of Clinical Trials independently).
Special knowledge or skills needed and/or licenses or certificates required
• Current, working knowledge of Code of Federal Regulations (CFR) Title 21 Part 314.80, Part 314.81, Part 314.98 and related FDA guidance
• Hands on experience managing multiple Clinical Trials (of varying phases) simultaneously
• Experience developing and presenting logical solutions to complex problems proactively prior to study impact
• Thorough working knowledge and understanding of cGCPs, ICH and regulatory guidelines and their implementation in Clinical Trials
• Proficiency with Microsoft Office including MS Project
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid
