This position is accountable for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials.
Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input.
This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables.
Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
Reports to the Clinical Operations Lead or above. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables and may provide supervision and coaching to supporting Clinical Trial Managers, including contractors.
Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
Lead feasibility assessment and selection of countries and sites for trial conduct
Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
Participates in inspection readiness activities including coordination of clinical study team deliverables
Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
Facilitate and manage regional KOL interactions, as applicable
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials
Qualifications
BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires proven project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
