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Job Detail


Clinical Trials Management Associate - II


Foster City, CA

Posted on Jun 12, 2018

Sr. CTMA - Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects:
• Serves as the key operational contact with external investigators and internal stakeholders.
• Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications.
• Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or product support are processed in a timely manner and to high quality.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains on track.
• Maintains efficient collaboration with company's Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.
• Acts as primary contact for study drug planning and shipping with Materials & Logistics.
• Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.

• Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
• Provides monthly study updates to the appropriate internal stakeholders.
• Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
• Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
• Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
• Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
• Organizes and leads review/approval meetings for CO proposal.
• Actively participates in Clinical Operations Quality Initiatives.
• Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
• Performs administrative duties in a timely manner as assigned.

May contribute to sponsored studies:
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• May resolve routine monitoring issues.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel is required.

Skills/Experience requirements:

Skills required demonstrating key core values of Integrity, Teamwork, Excellence, and Accountability
• Strong analytical, conceptual and business judgment skills.
• Excellent planning, organizational and administrative skills.
• Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently
• Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace with best practices in the industry
• Effective communication skills, both oral and written.
• Excellent problem solving ability.
• Effective project and time management skills.
• Tenacity and perseverance to ensure high level customer service.
• Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.
• High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution.
• Good understanding of financial systems and contracting process (desirable, but not required).
• Ability to understand clinical study protocols and efficient project management skills
• Working knowledge of ICH/GCP required. Phase research experience preferred.
• Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials and ability to understand clinical study protocols

• Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
• Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Onsite Offsite: Onsite Offsite Onsite

GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran’s status or any other category protected by law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities and/or employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training.