Objectives and Scope of Position:
Senior/ICTM is the core PDMA Clinical Operations role responsible for providing the operational expertise and leadership to one or more cross-functional study management teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP, GVP, applicable regulations and evidence generation class (e.g. sponsored, supported and RWD).
Summary of Main Responsibilities:
Builds and leads effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
Creates team culture and promotes team spirit.
Leads, develops and maintains effective working relationships with Study Management Team (SMT) members, with particular focus on affiliate members, external providers and collaborative partners.
In collaboration with functional management, coaches, supports, and provides study specific direction to Study Management team members.
Oversees the development and maintenance of study specific manuals.
Responsible and/or contributes to the development and management of the study timelines, resources, budget, risk and quality plans
Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the ICPL
Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the ICPL. Establishes study milestones and ensures accurate tracking and reporting of study metrics
Provides clinical operations expertise to ensure operational feasibility and delivery
Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies based on feasibility data and input from the CRO and affiliates and in consultation with the ICPL
Analyses the feasibility data across countries with input from the affiliates and provides the strategic country and site distribution and patient numbers to the ICPL
Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes
Oversees forecasting of clinical/non-clinical supplies
Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator, affiliates and ICPL
Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study
Delivers the operational elements of the study plan
Leads and chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings
Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met
Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the ICPL and implements contingencies in consultation with the ICPL
Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action
Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits; ensures inspection readiness of the study at all times (eTMF)
Oversees the maintenance of drug supplies and resolution of issues with input from Clinical Drug Supply coordinator
Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs
Develops, obtains endorsement and oversees the SMT goals, and makes sure that all efforts are made by the extended SMT to achieve them on time.
Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS), including selection, independent negotiation of scope of work, budgets, performance management, and issue resolution
Develops and executes appropriate site and CRO/vendor audit and quality plans in collaboration with PDQ
Identifies areas of best practice and process improvements
Participates in initiatives and programs as assigned
Maintains oversight and ensures consistency of the operational aspects across studies within a project
Ensures study adherence to ICH/GCP, GVP, Roche policies and SOPs Compliance
Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g. Roche Code of Conduct, applicable Roche directives, guidelines and SOPs)
Completes all required training modules as a priority
Professional and Technical Requirements:
Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
Responsibilities
Technical Competencies:
Ability to work across organization at all levels Ability to successfully achieve results within a multi-cultural diverse team Excellent analytical and oral written communication skills Strong project management and operational skills Forward thinking and creative solution development Sound understanding of legal agreements Ability to influence and negotiate Excellent Customer Mindedness Ability to quickly establish trusted partnering skills Fluency in written and spoken English
Experience, Knowledge, Skills
Minimum 3 years of professional experience in Pharma industry and / or Clinical Research Organization Experience including the set-up of evidence generation activities for sponsored, supported or real world studies. Project Management experience Experience working in a cross functional/ multicultural environment Relevant scientific knowledge Drug development and regulatory requirements for the conduct of clinical trials
Other:
Some travel may be required to attend study related meetings
Decision-Making Authority:
Study organization, set up and follow -up