Clinical Document Lead
2 weeks ago
TransPerfect Is More Than Just a Job…
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 100+ offices has its own individual identity, and each also has its own unique rewards.
Summary:
This is a senior-level role reporting directly to the Clinical Document Team Manager (CDTM). The Clinical Document Lead (CDL) is responsible for the high-level QC of the eTMF and for all work completed by the Clinical Document Specialist (CDS) Team. As a senior employee, the CDL is involved in helping to mentor and train new employees with direction from the CDTM. The CDL is also r sponsible for reporting on deadlines to the Project Manager and Client when needed. When the CDTM is not available, the CDL is responsible for interacting with the internal team and other departments.
Responsibilities:
* Responsible for review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO
* studies
* Proactive in researching eTMF or available resources to find answers to the queries at indexing and review
* stage, before they are escalated to PM/client
* Conduct retraining for team members as required on an ongoing basis keeping PMs and Senior TMF Quality
* Specialist in loop.
* Conducting trainings for new hires in collaboration with CDTM
* Ensure smooth functioning of assigned projects from start to end
* Manages Q&As for assigned projects
* Coordinate with PMs for requirements of updates in system configurations or mapping documents
* Assist the PMs in client meetings or provide them with required data on assigned projects as needed by the
* clients
* Assist Senior TMF Quality Specialist in performing internal audits when needed
* Review audit plans before finalizing with the client and ensure the internal audits are performed as per the
* audit plan
* Suggest improvement to the processes and performances of fellow team members
* Mentor fellow team members as required
* Coordinate with global team members to ensure the consistency in assigned projects
* Assist with User Acceptance Testing during product development and release
* Work with cross functional teams including Project Management, Business Development, Client Services,
* Development, and IT on the implementation and management of client projects
* Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to
* Development Team
* Serve as part as the Project Team on client projects
* Become an expert in the TMF Reference Model and stay current on regulatory changes
* Become an expert in Trial Interactive features and functionality and work with the Director of Clinical Operations,
* Project Management, and Development to recommend new features and functionalities to improve the
* product and reduce manual activities
* Respond to client requests for new project initiatives; collaborate with various members of the Production
* and Sales teams to assess the scope of work and produce cost estimates
* Take a proactive role in learning about clients' industry, business needs, and company culture, educating the
* Project Team, identifying new business opportunities, and providing a high level of service
* Line manage individual employees or groups, as required
* Set and fulfill client expectations
* Perform other special projects or duties when required
* Complete all other tasks that are deemed appropriate for your role and assigned by your manager/ supervisor
About You:
* Knowledge of clinical development phases and processes, including GCP and ICH regulations
* Expert in TMF filing best practices, clinical documentation at all levels
* Superior written and spoken communication skills in English
* Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
* Proficiency in Document Management (Adobe professional, knowledge of Scanning, indexing, using ISI Tools
* and Capture Perfect)
* Support supervisor in people management and administrative task.
* Minimum bachelor's degree or its equivalent
* Minimum 5 years of experience in the Life Sciences industry
* Experience with essential documents and other study documentation
* Hands-on experience project management practices and priority setting
* Proficient in client interaction and deliverables
A plus if you have...
* Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site or eTMF
* Experience in a leadership role, mentoring, training, performance evaluations, etc.
* Minimum 6 months of experience of supporting line management
* Ability to multitask in a fast-paced environment
* Work well with people from a variety of different backgrounds and cultures
* Build relationships with clients and co-workers
* Can work independently and as part of a team
* Take proactive measures to solve problems and commit to a high level of service
* Able to manage team building, coordination, and utilizing the skills
* Skilled in performing quality assessment and designing corrective actions
* Excellent project management and client interaction
* Expertise in handling escalations from internal and external clients
* Proficient in receiving feedback and escalations as an opportunity to improve
TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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