What are the responsibilities and job description for the Senior CTM position at System One?
Title: Senior Clinical Trial Manager
Location: Must be local to Florham Park, NJ and go onsite 2-3 days a week
Type: Perm
Start Date: ASAP
Leading Pharmaceutical Company located in NJ is hiring a Senior Clinical Trial Manager with 5 years industry experience. If you want to be a part of this groundbreaking work, please apply!
Description
The Senior Trial Manager, Clinical Operations (Sr. CTM) is responsible for conduct of global clinical studies. With minimal oversight, manages CRO and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations.
RESPONSIBILITIES
Location: Must be local to Florham Park, NJ and go onsite 2-3 days a week
Type: Perm
Start Date: ASAP
Leading Pharmaceutical Company located in NJ is hiring a Senior Clinical Trial Manager with 5 years industry experience. If you want to be a part of this groundbreaking work, please apply!
Description
The Senior Trial Manager, Clinical Operations (Sr. CTM) is responsible for conduct of global clinical studies. With minimal oversight, manages CRO and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations.
RESPONSIBILITIES
- Oversee and manage all operational aspects of phase I – IV global clinical trials in order to achieve a high-quality product for the marketplace and business success.
- Manage external partners, consultants, vendors, and budget to ensure the timely and cost-effective implementation of clinical trials.
- Coordinate the assessment of CROs and preferred vendors for implementation of clinical development plan. Review contracts, work orders, and invoices prior to submission to senior management for approval.
- Responsible for resource requirements (time, financial, manpower) within Clinical Research and management within agreed upon parameters.
- Responsible for completeness and accuracy of the study synopsis, protocol, case report, informed consent forms, clinical study reports, Annual Reports, and IB.
- Responsible for leading protocol and study specific clinical and operational meetings.
- Contribute to and support selection of all study-related vendors.
- Accountable for working closely with Biometrics, Data Management, Pharmacovigilance, and the CRO (when appropriate) to complete data management and bio-statistical analysis and oversee adherence to study timelines and data quality. Oversight includes the following areas: query resolution, logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing.
- Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, closeout, and completion of Trial Master File.
- Responsible for initial RFP obtainment and contributes to CRO/vendor selection
- Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass-through costs); as well as oversee scope change negotiations.
- Responsible for negotiating site CTAs in conjunction with the Legal Department and CRO.
- Responsible for patient recruitment and retention plans
- Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third-party deliverables.
- Responsible for collecting, preparing, and reviewing regulatory documentation for IRB submission prior to study start-up.
- Responsible for participating and presenting at Investigator Meetings.
- Responsible for program level budget forecasting and quarterly review.
- In conjunction with Drug Supply, responsible for assuring sufficient clinical drug supply is packaged, available, and shipped to sites for study start-up, and that sufficient supply are maintained during the study.
- Responsible for assuring accurate drug accountability/reconciliation for IP issued during the study to the site and at the end of the study.
- In conjunction with CRO responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.).
- Responsible for preparing and/or presenting executive management slide decks.
- BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification preferred
- At least 6 – 8 years of clinical research experience, with a minimum of 4 years having effectively led a project from inception to completion coupled with demonstrated ability to hold team members accountable with minimal oversight.
- Demonstrated expertise in daily oversight of CRO relationships and activities and a track record for completing trials on time and within budget.
- Knowledge of pharmacokinetics and pharmacodynamics with other supportive scientific and/or medical background.
- Experience and knowledge dealing with Phase 1 studies is an advantage.
- Significant knowledge of pharmaceutical industry, drug development, and regulatory processes in order to maintain compliance with all applicable regulatory guidelines, GCP and Company SOPs and policies.
- Proficient computer skills and knowledge of standard office software.
- Ability to travel 10%-15% including possible international travel.
- Must live a commutable distance to US Corporate offices in Florham Park, NJ
- Previous experience as a Clinical Research Associate preferred, but not mandatory. Strong written and verbal communication skills along with excellent interpersonal skills.
- Able to make effective presentations across functions and to senior management.
- High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines.
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