Manager, Clinical Document Management - REMOTE

Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 23, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVE/PURPOSE

The Clinical Document Manager is responsible for management of assigned Clinical Document Management Specialists (CDM) ensuring optimal use of resources and skillsets to deliver effective clinical document and Trial Master File (TMF) lifecycle management and support for Global Development Op-erations (GDO). The CDM Manager will be responsible for direct line management, ensuring appropriate training and oversight to ensure consistent and high-quality trial support across programs.

Partners with Head of CDM and R&D Functional Area representatives to execute strategies and depart-mental goals in relation to TMF and Records management for Takeda's global portfolio. Acts as CDM project lead and subject matter expert to oversee execution complex projects (e.g., integrations and divestments, process optimization, eTMF strategies, processes and reporting.
With a focus on inspection readiness for TMF, supports and may serve as TMF Lead for, activities in preparation for regulatory inspections and audit.

ACCOUNTABILITIES:
In collaboration with Head of CDM, ensures effective CDM resourcing to support clinical document and Trial Master File (TMF) lifecycle management and support across the trial porfolio. Ensures consistency with CDM support and compliance across projects.
--- Contributes to development of and leads assigned departmental objectives, representing CDM globally. Develops and implements clinical document processes to enhance support and com-pliance.
Acts as CDM lead to support complex activities (e.g., company acquisition and eTMF optimization projects)

--- Manages day to day activities of the assigned staff providing guidance, coaching and supporting issue escalation.
--- Motivates the team to achieve organizational goals, delegating tasks and implementing timelines to achieve targets to ensure high quality service and outstanding stakeholder support.
--- Ensures all employees receive appropriate training and education.
--- Empowers team members with skills to support development growth and subject matter expertise.
--- Supports team to successfully achieve individual business and development goals supporting issues and providing guidance on a day to day basis
--- Provides informal feedback on an ongoing basis and formally in the annual performance evaluation process to support continued development growth
--- Contributes to staffing for CDMTS through the appropriate hiring, performance management and succession planning
Promotes a positive, results-driven environment which models teamwork and provides visibility into suc-cesses.
With a focus on inspection readiness, monitors CDM compliance of the clinical TMF and lifecycle man-agement of TMF records.
--- Monitoring compliance of clinical document management deliverables and overseeing re-sources in the execution of inspection readiness plans.
--- May serve as TMF Inspection Lead for regulatory inspections of Takeda, resposible for ensuring execution of IR strategy and presentation/SME of TMF Process to inspectorate.
--- Provides subject matter expertise, guidance and training to functional teams at all levels.
--- Participates in workgroups for SOP and process optimization. Supports corrective and preven-tative actions identified through audit.
--- May lead selected clinical records activities in collaboration with CDM.

CORE ELEMENTS RELATED TO THIS ROLE

--- The Clinical Document Manager manages a team of Clinical Document Management specialists, en-suring optimal use of resources and skillsets to deliver effective Trial Master File lifecycle manage-ment and support across a large portfolio.

--- Contributes to development of and leads departmental projects in support of company goals and pro-cess optimization and efficiency. Serves as subject matter expert and leads complex projects working in collaboration with other functional Managers.

--- The Clinical Document Manager supports inspection readiness for Takeda leading execution of strategies and resources and may serve as TMF Lead, preparing and presenting to the inspectorate.

DIMENSIONS AND ASPECTS:
--- Provide expertise in complex Trial Master File Deliverables, Trial Master File structures/eTMF systems, and operating model to study teams.

--- Current awareness, understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research.
--- Comfortable with technology and able to learn new systems quickly.
--- Strong knowledge of eTMF (Veeva Vault preferred) and Microsoft applications.
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
--- Ability to communicate and influence stakeholders
--- Managing deliverables; demonstrating the ability to lead others to drive deliverables forward.
--- Navigation of changing priorities and communication about changes.
--- Leads team in manner which motivates, provides stretch goals and supports a culture of continued personal growth and development within Takeda.
--- Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
--- Ability to work in a fast-paced environment with demonstrated ability to manage mulitple competing tasks and demands.
--- Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed.
Interaction (The span and nature of one's engagement with others when performing one's job, internal and external re-lationships)
--- Must be able to professionally interact and communicate with internal departments at all levels of the organization internally and with external vendors.
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
--- Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis and audit outcomes.
--- Participates in workstreams which contribute to the development, implementation and successful adoption of R&D systems and processes.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
--- Overseeing TMF deliverables and for a large cross-therapuetic portfolio.
--- Optimizing the resources and skill sets of a team to deliver targets and work in a cross functional setting on trial execution
--- Interactions with cross functional teams and business units including Senior program or function management.
--- Composing and approving process documentation, establishing priorities, scheduling, and meeting deadlines.
--- Supporting inspections and directly presenting to inspectorate.
--- Ability to take ownership and manage tasks, as well as communicate effectively.
--- Working on multiple assigned projects which may be complex and/or high risk.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

--- Education: Bachelor's degree or equivalent preferred

--- Experience: Minimum 5 years plus experience in pharmaceutical industry, clinical research organization, or related role.
--- Strong knowledge in TMF and records management and oversight.
--- Experience in regulatory agency inspection(s)
--- Understanding of ICH/GCP and other application reguations pertaining to Trial Master File management for clinical trials and regulatory submissions. Skills:
--- Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
--- Demonstrated awareness of sponsor oversight and TMF
--- Demonstrated ability to work independently, take initiative, complete tasks to deadlines
--- Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
--- Strong communication skills and customer focus with ability to interact in a global, cross-functional organization
--- Proven ability to communicate effectively with external vendors, including issue escalation, training and responding to inquiries and concerns
--- Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks and demands
--- Experience mentoring or supervising other members of staff in some capacity, direct line management preferred.
--- Experience with use of Electronic Document Management Systems and Electronic Trial Master File Systems, Veeva preferred.
--- Advanced computer proficiency
--- Demonstrated ability to be flexible and to adapt quickly to change
--- Excellent teamwork, organizational, interpersonal, and problem solving skills.

COMPENSATION

Base Salary Range: $102,000 - 146,000 based on candidate professional experience level. Employee may also be eligible for Short-term and Long-term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
. click apply for full job details

Keywords: Takeda Pharmaceutical, Newark , Manager, Clinical Document Management - REMOTE, Executive , Newark, New Jersey