This role will support the Clinical Trial Transparency department to effectively and efficiently project and quality manage Transparency activities via internal teams, embedded teams and external vendors. The goal is to enhance coordination of projects and compliance oversight of transparency activities consistent with Takeda policies and local regulations and industry requirements.
The Clinical Transparency Manager will provide internal Takeda support for planning the assignment of work to vendors (disclosure team and data sharing team), planning for development of vendor capabilities, transfer or maintenance of systems to vendors, support for cross-functional Takeda strategic implementation to new regulations or policies/process, and ad hoc projects.
Establishes processes and routine checkpoints for near real-time compliance assessments consistent with applicable requirements, policies and procedures. This will be achieved by providing project management support for regular-internal compliance assessments and periodic audits of outsourced activities/systems (via Quality department or others). As needed provides support for budgeting/contracting and invoicing processing, IT/system projects and testing and other cross-functional projects, system developments, and applicable website projects (eg TakedaClinicalTrials.com).
- Project Management coordination of Transparency activities under Takeda Policies and Processes: Manages clinical trial transparency activities for all Takeda clinical trials to ensure activities are harmonized worldwide, and comply with all applicable US and international laws, regulations, industry requirements, and Takeda transparency procedures and commitments.
- In collaboration with appropriate parties works to develop and execute the Global Transparency Plan(s) that provide visibility of current and pending projects.
- Verifies that transparency plans are executed according to planed milestones and triggers and escalates any at risk or compliance issues to management.
- Develops project management and compliance tracking methodologies and dashboards for the effective work management.
- Monitors metrics of project management activities and evaluates needs to alter process to maximize efficiencies and compliance.
- Project Management coordination of major Ad Hoc projects:
- Manages the implementation of majors clinical trial transparency short to mid-term ad hoc projects including (but not limited to), pilot implementation programs, in-licensing alliance management coordination, transparency transfer for acquisition/divestiture of assets.
- In collaboration with appropriate parties works to develop and execute the Ad Hoc Project Plan(s) that provide visibility of current and pending projects and ensures efficiency
- Compliance assessment coordination: Provides support for department to coordinate with quality assurance, office of ethics and compliance, and external parties/consultants to perform transparency and system compliance audits to verify Takeda policies and processes were followed in compliance with all applicable disclosure and data sharing transparency requirements.
- Develops routine compliance checks and balances with vendors and teams and coordinated periodic assessments of the outcome of these routine checks to evaluate if changes are needed to processes. This reflects the importance of constant active management of transparency compliance as requirements change.
- This includes quality control review of publicly disclosed information to ensure information is updated appropriately.
- Ensures records maintained internally and by vendors are accurate, complete, and retained for proof of regulatory compliance if needed.
- Develops and maintains any internally required Clinical Trial Transparency records/logs/database of compliance.
- Manages vendor(s) budget and contracts to ensure continuity of services and that maximum cost-savings are maximized in parallel with the level/quality of service.
- Accountable for vendor budgets and invoices.
- Accountable for project management and processing of contract, statement of work, purchase order and other outsourcing administrative tasks.
- Supports internal Takeda transparency communication and participation in internal (eg: cross-functional initiatives) and external industry groups/committees (eg: PhRMA, DIA etc) to support development of strategy, best practices, and/or methodology for clinical trial transparency.
- Effectively communicates and coordinates efficient and accurate transfer of information, project plans and escalation of issues relating to clinical trial transparency to manager and Development Operations leadership.
- Coordinates the hosting of Transparency Steering Committee meetings and other departmental meetings as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s degree in science or communication
- Advanced degree preferred (e.g. Science, Regulatory Affairs, Research)
- 5 years of experience in the pharmaceutical industry or equivalent experience (e.g. academic research, contract research organization, medical writing).
- 2+ years experience with clinical trial transparency, project management or quality assurance.
Knowledge and Skills:
- Solid understanding of clinical development, including the phases, processes, and scientific methodology used within a clinical development program from protocol design through regulatory submission.
- Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to good clinical practice and clinical trial disclosure.
- Ability to effectively develop and implement project or compliance plans.
- Understanding of how to develop, apply and evaluate effectiveness of policies, procedures, and work instructions to ensure compliance to national, international, and corporate requirements for clinical trial trasnparency.
- Ability to manage contract processing and establish budget and invoice oversight procedures to maintain departments targets.
- Demonstrates problem-solving and interpersonal skills that facilitate effective interactions within global cross-functional teams and vendor(s).
- Ability to identify issues and generate solutions or request appropriate intervention by management.
- Ability to effectively manage multiple projects simultaneously.
- Demonstrates advanced computer software and system skills.
- Ability to sit and stand for long periods of time.
- Manual dexterity to operate office equipment (i.e. computers, phones, etc.)
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires less than 10% travel.
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