Longevity Industry Jobs

The Senior Clinical Trial Associate (Sr. CTA) will support the Clinical Operations Department and the Clinical Project Manager (CPM) across one or more clinical trials day to day activities. This individual is responsible for tracking deliverables and ensuring their assigned activities are performed in accordance with Clinical Operations standards and in compliance with FDA, GCP, ICH guidelines and applicable regulations.

Major Responsibilities:

• Increasing support of CPMs with various study start-up activities, including tracking and review of study metrics (enrollment, recruitment), protocol deviations, investigator site feasibility status, essential document review and investigational product release. With CPM oversight, the Sr. CTA may carry out assigned tasks and work independently, where appropriate.
• Supports sponsor clinical trial activities including participation in study team meetings, creating agendas, and managing meeting minutes.
• Assists in the management and oversight of Contract Research Organizations (CROs), vendors, and contractors, which may include managing correspondence, facilitating team calls (creation or collection of agenda, meeting minutes, action item follow up) and reporting/escalating deliverables to appropriate stakeholders.
• Coordinates clinical document management activities for multiple studies, including management of sponsor working files and Trial Master Files (TMF).
• Performs periodic ad hoc, interim, or end-of-study reviews and quality checks of TMFs, to ensure CRO’s TMFs meets sponsor’s expectations.
• Supports oversight of trial monitoring activities, which may include tracking/initial reviewing of monitoring visit report (MVR), managing closeout of action items and conducting sponsor directed co-monitoring visits.
• Supports the development and performs quality checks of study related plans such as TMF Plans, Monitoring Plans, Project Management Plans, Communication Plans, etc.
• Ensures consistency across assigned programs and identifies best practices and lessons learned.
• Supports CPM with site/vendor contract execution, vendor payments and overall study budget management.

Education & Experience:

• Associate’s or bachelor’s degree in a scientific or health-related field is preferred. Years of relevant experience will be considered.
• Minimum of three years of experience in clinical research is required.
• Minimum of three years of experience assisting in the management of clinical trials at a pharmaceutical/biotech company or CRO is preferred.
• Experience with DIA TMF Reference Model is preferred.
• Some site monitoring experience is preferred.
• Understanding of GCP/ICH guidelines and FDA regulations is required.
• Experience with various documentation management systems (e.g., eTMF, Clinical Trial Management Systems [CTMS] preferred).

Other Skills and Abilities:

• Must be proficient in MS Office Suite.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and timelines simultaneously.
• Excellent organizational skills and attention to detail are required.
• Strong proofreading, editing and reviewing skills are needed.
• Must be able to work independently, participate in meetings and possess problem solving skills.

Physical Requirements:

• The average travel for this position is 15% with some variation based upon the demands of the business imperatives.

The Sr. Clinical Project Manager (Sr. CPM) is responsible for leading one or more clinical project teams, developing comprehensive project plans, timeline/milestone management/adherence, and vendor management (including oversight of central laboratories, contract research organizations, and other vendors) across multiple protocols/programs. This individual is responsible for ensuring trials are managed in accordance with company standards and in compliance with FDA, GCP, ICH guidelines and applicable regulations.

Major Responsibilities:

• Responsible for overall project planning, initiation, conduct and closeout of multiple clinical trials in all phases of development.
• Leads the development of clinical protocols, amendments, informed consents, CRF/source documents, protocol specific training documentation, administrative letters, IND safety reports and other written clinical documents.
• Establishes and maintains productive working relationships with vendors, clinical investigators, and clinical site study staff to ensure quality of deliverables.
• Responsible for developing and facilitating request for proposals (RFP), bid reviews, and contracting with CROs and other vendors.
• Responsible for the development and negotiation of trial level and clinical trial site level budgets.
• Manages contract research organizations (CROs), vendors and contractors to ensure project requirements are met.
• Responsible for development, maintenance and oversight of project metrics (study start up indicators, actual vs. expected site initiations/enrollment), timelines/milestones, and trial budgets.
• Oversees data collection and responds to questions from clinical site study staff regarding the protocol and any other study related issues.
• Ensures that protocol/project training (e.g., Investigator Meeting) for investigators, study coordinators, monitors and other key study personnel is conducted and appropriately documented.
• Responsible for the oversight of site monitoring activities and review of associated documentation from study initiation through close-out.
• Responsible for ensuring management of the Trial Master File (TMF) during the trial and for completeness at end of study prior to archiving.
• Responsible to ensure inspection readiness throughout the study.
• Responsible for escalation of study, vendor and site issues in a timely manner.

Education & Experience:

• A Bachelor’s degree in a scientific or health-related field is required.
• Minimum of seven to nine years of general clinical research experience, including on-site monitoring experience.
• Must have a minimum of five to seven years of experience in the management of clinical trials as a project manager at a pharmaceutical/biotech company or CRO.
• Advanced understanding of GCPs, FDA regulations and ICH guidelines is required.

Other Skills and Abilities:

• Must be proficient in MS Office Suite including Microsoft Project and Excel.
• Must demonstrate a keen attention to detail and timelines.
• Excellent writing, communication, and presentation skills
• Demonstrated leadership and project management skills.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.

Physical Requirements:

• The average travel for this position is 20% with some variation based upon the demands of the business imperatives.

• Ph.D. in a relevant field (neuroscience, ocular disease, biology, pharmacology) or equivalent with 0-3 years of research experience (preferably in a biotech or pharmaceutical setting). A Masters in a relevant biological science with 5+ years of experience, or Bachelor’s in a relevant biological science with 5+ years of experience in a biotechnology or pharmaceutical company will also be considered.
• Evidence of scientific accomplishments in the form of publications and presentations preferred
• Demonstrated experience with cell-based assays, microscopy and/or high content imaging, and standard molecular biology techniques preferred
• Experience with biomarkers, proteomics, RNAseq, and bioinformatics a plus
• Experience running in vivo efficacy studies is recommended
• Experience generating high-quality data in a time-sensitive environment
• Experience with neurological and/or ocular disorders preferred
• Experience with lead identification/optimization using a combination of molecular, cellular and >in vitro/in vivo techniques a plus

• Excellent written and verbal communication skills; possessing the ability to describe research clearly and concisely to a cross-disciplinary audience
• Self-motivated and effective at managing multiple projects in parallel.
• Excellent organizational skills and attention to detail are required
• Intellectually curious, continuously driven to develop and improve scientific understanding and methodology