Alexandru Ulmeanu
Line Manager, TMF Department
Bucharest
Summary
Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Clinical trials professional, with more than 11 years’ experience in the CRO industry, particularly in Trial Master File (TMF).
Overview
12
12
years of professional experience
8
8
years of post-secondary education
1
1
Certification
Work History
Manager, TMF
Parexel International Romania SRL
Bucharest
1 2023 - Current
- Managing and overseeing team activities, ensuring appropriate resourcing of staff, staff assignments, and quality control of project deliverables and timely delivery of project deliverables.
- Improve cross-functional processes by implementing new initiatives.
- Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.
- Demonstrate leadership within department function, or location. This includes taking an active role in departmental, functional, or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate
- Supporting team members to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, Client feedback, audit results and QC measures
- Participate in and contribute to Project bids, including client presentations
- Meeting and aiming to exceed client expectations, retaining, and developing a skilled, experienced, and motivated team.
Associate Manager, TMF
Parexel International Romania SRL
Bucharest
01.2021 - 01.2023
- Meet and aim to exceed client expectations, retaining and developing a skilled, experienced, and motivated team
- Support efforts for generating business leads (client networking, public speaking, etc.) Monitor performance and provide technical support to team members to ensure the required knowledge to fulfill their duties
- Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
- Provide consultation, facilitate metrics collection, and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget
- Responsible to coordinate client or account activities for department or function, acting as Subject Matter Expert
- Meet client and business needs to have all projects optimally resourced with suitably experienced staff
- Produce accurate resourcing plans in conjunction with the appropriate Project Team Members
- Check quality of team deliverables (e.g., TMF overview) and take appropriate remedial action
- Participate in Parexel and department system/standards improvement activities
- Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel WSOPs
- Maintain a positive, results orientated work environment, building partnerships, and modelling teamwork, communicating to the team in an open, balanced, and objective manner.
TMF Partnership Lead
Parexel International Romania SRL
Bucharest
01.2020 - 01.2021
- Responsible for the development, testing and implementation of partnership related specific processes as the RM Business Process Owner for partnerships
- Function as the main RM contact and SME for the partnership office, the Portfolio Directors and Project Leaders as well as other department BPOs
- Liaise with the Partnership TMF representatives for coordination and oversight purposes
- Responsible for the set up and monitoring of partnership relevant RM performance and process metrics
- Accountable for the timely delivery of agreed outputs, when leading initiatives
- Can be assigned to departmental or cross departmental initiatives as contributor providing RM relevant input, or to lead these initiatives
- Upon Partnership PD request provide SME input to negotiations with the clients on specific deliverables and partnership processes
- Provide input to RM costing for partnership projects or services upon request
- Provide guidance to the Partnership TMF representatives to ensure a seamless service delivery
- Responsible for the training and mentoring of Partnership TMF representatives
- Support the TMF representatives on partnership projects with audit preparations, QC relevant documents and attend audits as RM representative, as needed
- Works closely with the RM Line managers on resourcing and performance related questions of TMF representatives who are assigned to partnerships
- Review and provide input to Service Operating Models and Partnership SOPs; participate in the agreed change process of partnership documents and ensure that the agreed change management and documentation rules are followed
- Constant review of partnership processes to initiate and lead process improvements, as required, to ensure cost efficient and high-quality service delivery and client satisfaction
- Ensure timely and appropriate escalation of any partnership related issues which require senior management support
- Promptly follow up on any incompliances and audit findings related to Partnership with RM involvement, coordination of appropriate actions and close out of actions; timely documentation of quality issues and related actions, as well as reporting back to clients as needed in cooperation with the partnership PD
- Attend regular client and internal progress and metrics review meetings, PL/PD team meetings and RM partnership team meetings, as needed.
TMF Lead
Parexel International Romania SRL
Bucharest
01.2019 - 01.2020
- Participates in study kick-off meeting and drives discussions regarding design of TMF plan
- Provides recommendations in terms of and client expectations for TMF, including budget and resources implications
- Works with the PL to set realistic client expectations and enable client TMF oversight
- Coordinates TMF milestones in collaboration with the TMF reviewer and/or other TMF contracted tasks according to the established timelines and quality criteria
- Provides input to relevant project guidelines as required
- Proactively flags potential project risks in terms of TMF deliverables and provides feedback to project team and client to design solutions
- Leads or participates in internal monthly TMF review meetings, regularly providing TMF status updates
- Provides TMF expertise to manage client concerns in terms of TMF
- Identifies inconsistencies and inefficiencies in processes and recommends solutions
- Recognizes out of scope activities and communicates to responsible Project or Functional Leader
- Assesses required resources against study QC plan / study TMF milestones, study budget/hours and other key factors directly impacting TMF QC plan / milestone reviews, where applicable
- Provides feed-back to PS/FL Super Users in CRS Technology in order to enable enhanced systems, tools and processes
- Maintains proactive communication and collaboration with Clients
- Monitors and evaluates TMF Inspection Readiness status, employing available tools and metrics, escalating concerns and proposing action items to the study team if needed
- Maintains the TMF for ongoing studies according to Parexel SOP’s or contractual obligation to sponsor; if required may perform completeness checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria
- Takes proactive measures to prepare studies for audit and inspection preparation
- Attends audits and inspections as TMF representative
- Manages TMF tools customization and TMF Plan / CFMP development, updates and sign off
- Fully able to deliver training and mentoring for junior team members
- Identifies best practices developed during project and shares lessons learned across the organization or at project level, as applicable
- Proactively flags re-training needs for study team on general or study specific TMF requirements
- Collaborates with Project Leader and the other Functional Leads to confirm TMF activities are completed at study close out as required by Sponsor and Parexel procedures.
Senior Records Management Associate
Parexel International Romania SRL
Bucharest
01.2016 - 01.2019
- Create Central Files for new studies and maintain Central Files for ongoing studies according to PAREXEL SOPs or contractual obligation to sponsor
- Upload, apply naming convention and file Central Files documents in electronic document management system as required for project team
- Central File QC activities for assigned projects
- Participating in internal/ external/ sponsor audits for assigned studies
- Preparing and maintaining the tools necessary for the CF QC activities for assigned studies
- Support retrieval of documents as per audit requests
- Processing of wet ink documents
- Ensure up to date study documents in tracking systems/ document repositories
- Activities associated with Impact Harmony, as appropriate
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and WSOPs and study specific procedure
- Complete routine administrative tasks in a timely manner (e.g., timesheets, project metrics)
- Maintain quality control procedures to ensure accurate maintenance of files
- Perform archive procedures upon study termination: prepare copies of Central Files as required by Sponsor and PAREXEL Internal Records.
Records Management Associate
Parexel International Romania SRL
Bucharest
01.2013 - 01.2016
- Create Central Files for new studies and maintain Central Files for ongoing studies according to PAREXEL SOPs or contractual obligation to sponsor
- Upload, apply naming convention and file Central Files documents in electronic document management system as required for project team
- Central File QC activities for assigned projects
- Support retrieval of documents as per audit requests
- Ensure up to date study documents in tracking systems/ document repositories
- Activities associated with Impact Harmony, as appropriate
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and WSOPs and study specific procedure
- Complete routine administrative tasks in a timely manner (e.g., timesheets, project metrics)
- Maintain quality control procedures to ensure accurate maintenance of files
- Perform archive procedures upon study termination: prepare copies of Central Files as required by Sponsor and PAREXEL Internal Records.
Education
Management- Marketing - Management
Romanian American University
Bucharest,Romania 01.2009 - 04.2012
High School Diploma -
National College Mihai Eminescu
Buzau,Romania 01.2005 - 04.2009
Skills
Flexibility
Certification
Certification in Informatics
Additional Information
Business Process Owner, TMF Partnership Level., Ability to work in a matrix environment and to foster teamwork., KPI development, dashboards and targeted FU tools (Power Automate)., Master Study Agreements, Project Operational Manuals negotiations and development, Sponsor Qualification Audits, Experience in more than 40 Accounts., Experienced with audits – assistance provided on site in Sponsor Audit that led to no findings. Remote support and TMF Presentation for Internal and Sponsor Audits., Establishing clear goals and objectives to focus the team on achieving results., Mentorship and project specific training to new hires and active TMF Team Members, Clinical Team on FTQ and processes., Ensure adequate resources allocation for completing all tasks and effective delegation of tasks to team members., Over 11 years’ experience in coordinating RMA teams. Manage and coordinate teams of Monitors, Clinical Operational Leaders, Project Leaders in working with TMF and TMF associated systems and reports., Experience with multiple types of structures and TMF Plans – PXL Structure, Sponsor Structure. Create Hybrid structures and TMF Plans that combine PXL and Sponsor requirements., Experience in studies with paper and electronic documents, blinded and unblinded areas., Proficient user of VAULT, Sponsor Systems., Development of TMF Metrics Templates to be used at Sponsor Level on various projects., Development of TMF In Stream Initiative to improve TMF audit readiness., Improve the Subcontracted CRO SOP to enhance the collaboration with the subcontracted parties., Manage multiple studies and accounts at the same time (Enterprise and Biotech)
Languages
English
French
Training
- Finance Essentials
- Project Management Body of Knowledge (PMBOK)
- Project Management Simplified
- Artificial Intelligence for Project Managers
- Project Portfolio Management Foundations
- Building Business Relationships
- Excel: Power Query
- Solving Business Problems
- Leadership Foundations
- Exam Tips: Certified associate in project management (CAPM)
- Excel for Business Analysts
- Leading with Emotional Intelligence
- Leading with Stories
- Leading Productive Meetings
- Influencing Others
- Embracing Change
- Developing Political Savvy
- Mentoring Others
- Coaching and Developing Employees
- Building Customer Loyalty
- Leading a Customer-Centric Culture
- Leading and Working in Teams
- New Manager Foundations
- Excel 2013 Essential Training
Timeline
Associate Manager, TMF
Parexel International Romania SRL
01.2021 - 01.2023
TMF Partnership Lead
Parexel International Romania SRL
01.2020 - 01.2021
TMF Lead
Parexel International Romania SRL
01.2019 - 01.2020
Senior Records Management Associate
Parexel International Romania SRL
01.2016 - 01.2019
Records Management Associate
Parexel International Romania SRL
01.2013 - 01.2016
Management- Marketing - Management
Romanian American University
01.2009 - 04.2012
High School Diploma -
National College Mihai Eminescu
01.2005 - 04.2009
Manager, TMF
Parexel International Romania SRL
1 2023 - Current
Certification in Informatics
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