Senior Trial Manager, Clinical Operations - Florham Park, United States - Shionogi

Description

The Senior Trial Manager, Clinical Operations 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 for Shionogi Inc.
• 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.
• Establish and maintain effective communication and collaboration with functional area peers including Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs, Legal, Medical Writing, Biostatistics and Data Management to meet program objectives and support achievement of goals.
• 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 and 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.

Specific Duties

• Accountable for working closely with Shionogi 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, close out, 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 (ie. 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.

MINIMUM JOB REQUIREMENTS

• BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification preferred
• At least - 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.

PREFERRED SKILLS & EXPERIENCE

• 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.
• Demonstrated ability to resolve multifaceted problems and lead multiple projects of diverse scope, analyze data and exercise sound judgment.
• 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.
• Work comfortably within a fast-paced and dynamic work environment and ability to embrace change.
• Ability to work cross-culturally and lead by example in establishing a close partnership and maintain flexibility in a cross-cultural environment.

ESSENTIAL PHYSICAL REQUIREMENTS

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18" away from face for extended period of time - up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time - up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.


DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee.

Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc.

to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.