As the AD/Sr. Manager, Clinical Records Manager, you will oversee management of Takeda's clinical records in archive state to ensure compliance with regulatory requirements and Takeda policy, support preservation and retrieval of records to support Takeda business activities. Serving as subject matter expert for records management, you will contribute to the company and department goals, through management of programs and process development in collaboration with CDM Leadership, third-party archive vendors and team members. You will support inspection readiness for Takeda leading execution of strategies to provision records for audit and as subject matter expert, and presents to the inspectorate.
- Collaborate with representatives and external partners to support retention and accessibility of clinical records that have reached archive status to support Takeda's records management policies, regulatory filings, submissions, acquisitions and divestments.
- Maintain the operations of the physical records room(s) regarding archiving, indexing and retrieval of essential physical records. This also includes the management of clinical records held globally across Takeda external vendor off-site facilities.
- Maintain electronic records with Takeda content management system(s) and third-party databases.
- Ensure appropriate tracking to ensure efficient identification of clinical records across a network of systems and locations
Contribute to company and department goals and define/leads plans which help improve clinical records management, including records consolidation project(s); oversee delivery of clinical records to support divestment projects, annual destruction and retention reviews.
Develop clinical records management procedures.
Support preparation of documentation required for regulatory agency inspections and internal audits. May stand in front of inspector(s) during inspection.
Provide high-quality customer service and record assistance through all levels. In collaboration with Head of Clinical Document Management, outlines proposals to gain senior management approval for budget and resources to support plans to improve compliance and efficiency in clinical records management.
Manage daily activities of the assigned staff providing training and supporting issue escalation.
- Support team to achieve individual business and development goals.
- Provide feedback on an ongoing basis to support continued development growth.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor's degree or equivalent
- 8+ years' experience in pharmaceutical industry, clinical research organization, or records management related role.
- Demonstrated experience in managing direct reports and/or supervising team
- Current awareness of regulatory requirements for clinical trials (ICH/GCP) pertaining to records management preferred.
- Ability of records management program. Experience in pharmaceutical records management and understanding of associated regulatory requirements.
- Communicate with external vendors, including issue escalation, training and responding to inquiries and concerns
- Experience with use of Electronic Records Management Systems
- Leadership experience
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
North Carolina - Virtual