Accountable for leading the operational study team, which is responsible for the execution and delivery of
quality studies, including in-process quality control activities (e.g. quality checks and balances to ensure
inspection readiness, enrollment, metrics, milestones, timelines and budget).
This position requires advanced knowledge of the functional disciplines necessary to guide the operational objectives to
ensure execution and delivery of quality studies within defined timelines and budget.
Essential Job Functions
* As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s) (e.g.Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
* Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners
* Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI?s SOPs and policies.
* Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs
* Accountable for monitoring study operational plan, and managing operational study budget, timelines, and risk mitigation processes with input from key stakeholders
* Accountable for direct supervision and mentoring of Clinical Trial Managers
* Accountable for oversight of Clinical Trial Manager activities
* In collaboration with key stakeholders, responsible for supporting the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
* Accountable for the management and maintenance of the study TMF
* Accountable for leading, and managing the process for the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team, CRO Management,
* Accountable for operational review and input into the design and protocol for an assigned study
* Accountable for the development and management of integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities (e.g. Clinical Planning, RA, GDS, PR&D, R&D QA).
* Accountable for the development, implementation, and management of standard tools used to manage an assigned study (e.g. quality and performance metrics, timelines, critical path activities, milestones) as well as resources (e.g. timelines, budget, vendors, other)
* Accountable for providing input and guidance into the EDC/eCRF and eHELP (i.e. completion training guidance) development, UAT, and roll out, in collaboration with key stakeholders
* Accountable for providing input and guidance for setup of CTMS set-up, MUL (master user list), study specific internal and site training, in collaboration with key stakeholders
* Accountable for the management of core processes (e.g. Site management, investigator notification letters, protocol deviations, study feasibility and enrollment) with input from key stakeholders
* Accountable for managing the Trial Master File setup and ensures ongoing maintenance of TMF documents and documentation process/plan
* Accountable for the development of final Study/Country/Site Feasibility which informs final study timelines and budget
* Accountable for initiating and managing Pre Inspection Audit Readiness considerations for an assigned trial
Study Start Up Activities
* Accountable for the management of Non-Drug Site Supplies (study materials/equipment,/manuals), deliverable development, shipment, tracking and resupply to sites
* Accountable for the management of IRB submission process for start-up (Protocol and other study documents); Annual IRB update, Protocol amendments and study close out
* Accountable for the management of investigator site identification (e.g. site profile, PSSV review), qualification, and start up process with input from key stakeholders
* Accountable for overseeing site activation readiness (e.g. critical documents, supplies, training) and management
* Accountable for developing the agenda and managing the planning and execution of Investigator Meetings: Meeting vendor contracting and management, coordinate development of meeting agenda, content development and delivery of operational (non-Clinical Science) presentations and training materials, manage meeting execution and documentation; ensure input from key stakeholders; Shared accountability with Clinical
* Accountable for vendor selection (ECG, Lab, IWRS, IRB, Raters), contracting and selection process (e.g. proposals, selection, contracts, and specifications)
* Provides input into, and manages the selection, contracting and oversight of CROs and clinical trial related vendors (specifications, country/site selection, start up, conduct, close out, budget/invoices) in collaboration with CRO Management, Clinical Affairs, and key stakeholders
Study Drug Management
* Accountable for managing the drug supply process (e.g. recruitment hold, enrollment extension) with input from key stakeholders
Pharmacovigilance/SAE/AE Handling and Reporting
* Accountable for managing the distribution and tracking of alert letters to IRBs
* Accountable for reviewing quality and performance metrics to ensure alert letters were filed at the site, and acknowledged by the site in CTMS
* Accountable for providing oversight of specifications for CRO distribution and tracking of alert letters and submissions to ethics committee per local regulations
* Accountable for providing operational input into the development and management of the IQMP and Risk-Based Monitoring Plan for an assigned study
* Accountable for the development and management of process for identifying duplicate patients for an assigned study
* Accountable for ensuring documentation of medical monitoring finding/decisions/discussions for TMF
CSR Development and Reporting
* Accountable for providing operational support into the CSR
* Minimum of 5 years of pharmaceuticals/biotech experience
* Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
* Extensive experience in the operational and scientific/medical aspects of clinical development.
* Critical thinking skills, and ability to identify potential issues and solutions, across clinical development programs.
* Strong project management, leadership and mediation skills within a matrix environment. Continuous improvement experience preferred.
* Ability to work across broad range of interfaces, and take broad perspective to harmonize processes and procedures.
* Demonstrated ability to develop and manage end to end study operational plan
* Demonstrated ability to operationally execute and deliver a quality clinical trial
* Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams
* Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech
* Timeline, budget and resource management experience required
* Demonstrated experience in change management initiatives preferred
* Program and project management experience preferred
* International experience a plus
Knowledge, Skills, and Abilities
* Capable of performing all the roles defined in the preceding grade levels as required by clinical operations
* Knowledge of drug development and FDA GCP/ICH regulatory guidelines
* Understanding of clinical trial design
* Knowledge of PK/CMC requirements for studies preferred
* Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc.
* Clinical trial management system (CTMS) background is a plus
* Strong ability to manage within a matrixed organization, managing multiple tasks in a timely, budget-conscious manner
* Ability to identify and work with key stakeholders to deliver operational requirements
* Ability to consistently operationalize abstract ideas
* Ability to develop and implement methods to leverage resources across functions & business units to ensure achievement of organizational goals and objectives, which may include overall budgets, schedules and performance standards
* Ability to successfully manage and mentor indirect (e.g. CTM) reports to achieve departmental goals
* Ability to identify issues, analyze situations and provide effective solutions
* Must possess demonstrated superior skill in the following:
* Change Management
* Decision-making, Judgment, and Problem Solving?
* Interpersonal relationships, team building, motivating & mentoring associates and influencing others
* Initiative and Accountability
* Promoting Innovation and Process Improvement
* Strong oral and written communication skills
* Ability to embrace change and comfortable with ambiguity
Bachelor of Science degree; Advanced degree (e.g. Master, PharmD, PhD) preferred