Manager
Aragen Lifesciences Pvt Ltd
Hyderabad
06.2019 - Current
- Identified project scopes, timelines and budget for the contract development
- Identify and communicate project deliverables to all stakeholders
- Tracked project performance to analyze successful completion of short- and long-term goals
- Engaging internal and external clients to develop logistics concepts and solutions in order to meet study deliverables, objectives and profitability while achieving client satisfaction
- Ensure study/project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized
- Ensure that study specific management tools and documents are in place and constantly maintained
- Perform risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly Prepare, participate in and follow up on audits/inspections
- Undertake the full range of project-based duties relevant to the leadership, management, and development of the project team to ensure their performance meets and/or exceeds the requirements to be fulfilled both on the study as well as on a personal goals/objectives level
- Develop & manage execution of project or program related clinical supply, sourcing, manufacturing, distribution & laboratory logistics strategy with relevant stakeholders in line with applicable regulations
- Communicate with third party providers and negotiates scope of work in conjunction with procurement
- Utilize applicable tools for supply chain simulation and forecasting
- Develop, plan and manage inventory according to strategy, quantities and forecast
- Develop supply schedule, seeks feedback from Clinical team on study progress and adjust accordingly and provide feedback to depots
- Develop and implement production, depot and distribution strategy including collaborating with 3rd party depots with relevant stakeholders
- Overview the operational management of programs and assets
- Ensures study/project timelines and budgets are met in accordance with the contract agreement
- Finance and Profitability Management (Monthly, control, input) incl
- Client invoicing
- Maintain Parexel’s Internal Project controlling/Financial systems including but not limited to monthly revenue and forecasting
- Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl
- Invoicing
- Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner
- Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope) for professional services and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered
- Follow through on any CIS until signature
- Contributes to profitability/finance management (monthly reporting & forecasting, budget control, change in scope management)
- Act as main point of contact for internal and external customers and use a consultative approach in issue resolution
- Proactively engage with external and internal clients in solution improvements
- Work towards establishing positive relationships with internal and external clients
- If required actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, contracts negotiation and review) including client presentations
- Represent Parexel at professional meetings/conferences as participant and/or speaker
- Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations
- Lead project meetings and support team members to monitor and ensure that projects is completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GxP and/or any other guidelines to fulfil local regulations, including customs regulations
- Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits
- Performs risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly
- Ensure that study specific management tools and central file maintenance plan are in place
- Ensure project related training are properly assigned to project team members and their timely completion.