- Partner with Clinical Lead or Project Lead on study to ensure quality and on-time site deliverables
- Oversee project aligned CAS activities
- Oversee Centralized Monitors
- Proactively oversee country CRA / CTA study deliverables
- Act as main point of contact for Investigational Products (IP) and non-IP related issues
- Oversee system access management and support access related issues
- Oversee timely ISF virtual binder creation
- Annotate country / site file review checklists, follow up / provide oversight of action item resolution for site / country level checklists, perform cross checks as per TMF Quality Plan / RMP and oversee compliance of reviews
- Manage project resources (CRAs/CMs/CTAs/CASs)
- Perform trend analysis of clinical aspects of the trail
- Share trends and agree on action plans
- Review, triage and actions clinical study alerts
- Monitor Clinical Operation Plan compliance
What will enable you to be successful as a CML?
- Familiarizing yourself with the study protocol, study team, study systems, study specific requirements and deliverables.
- Proactively identifying risk through trending and analysis and taking actions to mitigate risk
- Applying strong time management, prioritization and communication skills
- Positive issue resolution
Required Knowledge, Skills And Abilities
- In depth knowledge of Clinical Research functions like Monitoring, Project Management and Regulatory.
- Strong knowledge of the components of the protocol
- Strong communication and interpersonal skills, including good command of English language
- Excellent problem-solving skills
- Good teamwork skills
- Ability to work under limited direction
- Basic software and computer skills, including MS Office applications. Familiarity with related systems and software utilized in clinical operations
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
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Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Manages DM-related aspects of the program and/or project
- Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
- Represent DM as the functional lead at internal and sponsor project team meetings
- Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
- Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
- Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
- Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
- Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
- Reviews and provides DM staffing projections for program and/or projects
- Presents EDC and/or CRF completion at Investigator Meetings
- Participates in regulatory and Sponsor audits for program and/or projects
Oversees daily team member activities
- Serves as a Data Management team leader
- Reviews DM team member activities and deliverables to ensure plans and processes are followed
- Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
- Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
- Provides training of DM staff on project specific processes
- Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:
- Discrepancy management
- Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
- Investigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews
- Assumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements
Oversees System Development and Modifications:
- Implements DM strategy on the project/program based on scope of services and as laid out by DM management
- Coordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing and implementation of all data capture tools
- Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines
- Coordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirements
- Coordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work.
- Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specifications
- Consolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisions
- Coordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects
Oversees System and Data Listing Testing Activities:
- Coordinates testing activities for the EDC technologies per scope of services
- Performs testing for EDC systems as required per scope of services and standard operating procedures
- Verifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests
- Provides feedback to the other project team members and managers to improve the deliverables.
Develops, Maintains and Archives DM Project Documentation including:
- Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required
- Data review listing specifications
- Database Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications
- Database lock documentation
Represents Data Management at Bid Defense Meetings (BDM)
- Prepares project-specific slide presentation from DM template functional slides
- Participates in BDM preparation meetings including discussing overall DM strategy
- Presents DM slides at BDM and constructively participates in discussion
- Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates
- Serves as Data Operations mentor
- Creates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)
- Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lock
- Provides open environment for question/issues about DM topics from within department and cross-functionally
KNOWLEDGE, SKILLS AND ABILITIES:
- Team player with ability to learn new skills, tasks and technologies and teach others
- Ability to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc)
- Ability to effectively communicate technical issues to non-DM team members and Sponsor
- Ability to maintain positive and open relations with internal, sponsor, and vendor team members
- Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes
- Ability to develop study-specific procedures
- Knowledge of clinical trials concepts
- Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, Database design documents, edit check specifications, Data Review Plan, etc.)
- Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
- Proficiency with IQVIA Biotech SOPs, WPs
- Efficient with organizational skills to meet established timelines
- Organized and thorough with attention to details
- Excellent verbal, written and listening communications skills
- Effective interpersonal skills including ability to provide and accept constructive feedback
- Effective logical thinking ability regarding problem-solving skills
- Proficiency in computer applications and time management tools (e.g., MS Office)
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- As a Senior Patient Recruitment Lead you will be at the core of delivery of patient recruitment and retention solutions.
- You will have a key role in the implementation and delivery of innovative deliverables to enroll and engage patients in clinical trials.
- You will work very closely with the clinical and project leadership teams, and partner with our in-house experts such as Technology, Data sciences, Marketing, Creative and Content Development.
- You will lead and oversee large, high-value programs and complex projects and be responsible for program/project success, including meeting key performance metrics, delivering within budget and customer satisfaction.
- You will identify potential opportunities for new scope to be added to maximize delivery using creative thinking and engaging with the Strategic Lead team.
- You will lead innovation implementation through process review, driving improvement activities and creating/delivering training as the Subject Matter Expert for products, services and industry trends.
- You will be a champion for our end-to-end solutions to both our internal and external clients.
- You will also be a role model for our junior members of staff and support with their mentoring and development. You will be supported in your own career development activities with multiple opportunities within Strategy, Delivery, Team leadership, Site support and Marketing.
- Collaboration with internal delivery teams to manage the coordination, planning and implementation of Patient Recruitment and Retention tactics, proposed by the Strategic Lead team, to positively impact recruitment and retention rates for large programs and complex studies.
- Serve as the primary point of contact for clients and the ultimate responsible for the execution and delivery of the Patient Recruitment scope, as defined by the Strategic Lead team and per the contract with IQVIA.
- Serve as the patient recruitment expert for internal project teams, clients and other internal stakeholders to implement and deliver operational recruitment plans on new and/or existing projects needing recruitment and retention services.
- Work as a partner with the Clinical Lead on recruitment strategy plans development
- Communicate with clients and project teams to implement, monitor and report on the impact of recruitment/retention tactical plan; proactively make additional operational and tactical recommendations based on study performance.
- Lead operational and tactic-related project activities for the study team and clients to ensure that overall project milestones are met.
- Manage the scope of work, objectives, quality of deliverables and other activities of assigned projects (based on scope, may manage a team of Leads and Specialists) on time and on budget.
- Management of assigned project budget(s) to meet financial and company goals.
- Responsibility for financial reporting, tracking and ensuring the financial health and success of the project.
- Develop and implement risk management plans for minimizing impact on project objectives and deliverables.
- Represent IQVIA Patient Recruitment at site/client-facing meetings (i.e. Kick off meetings, Investigator Meetings, Face2Face, etc.) to present strategy/rationale, train CRAs and site staff, and conduct recruitment support workshops as required.
- Maintain knowledge of current recruitment trends, vendors, deliverables and technologies to increase productivity and recommend additional support as needed.
- Provide technical expertise as able in support of project-specific and interdepartmental training efforts.
- Support continued process improvement to ensure quality in the unit.
Required Knowledge, Skills And Abilities
- Strong project management experience including directing a team and management of budget and financials.
- Work well under pressure and ambiguity
- Excellence on client management skills
- In-depth knowledge of the drug development processes across all functional areas.
- Knowledge and ability to apply ICH Good Clinical Practice and applicable regulatory guidelines.
- Comfortable working with data and technology.
- Excellent organizational, collaboration and problem solving/critical thinking skills.
- Excellent time management skills and ability to manage competing priorities.
- Strong interpersonal skills and impactful presentation skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Knowledge of the digital development process as well as the creative process is preferred
- Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word and Excel.
- Excellent written and verbal communication skills including good command of English.
- Ability to influence effectively within IQVIA team and project teams including Therapeutic Strategy Lead, Project Lead, Clinical Lead, CRA and the client.
- Ability to work creatively and independently in a complex global environment.
- Ability to adapt and be flexible to changing priorities.
Minimum Required Education And Experience
- Bachelor’s degree in a healthcare or other scientific discipline or educational equivalent; 6 yrs. of relevant industry experience; or equivalent combination of education, training and experience
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communications requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- May require some travel.