Work as Clinical Project Manager at Bayer
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power. Our products help address some of today’s biggest challenges, including global population growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources.
Post : Clinical Project Manager
The Clinical Project Manager (CPM) in the Oncology Strategic Business Unit is responsible for the strategic planning, operationalizing, tracking and management of a Clinical Development Project led by a Global Clinical Leader (GCL) or Early Clinical Leader (ECL). The CPM focuses on milestones, costs, FTE’s and quality, and early risk identification and risk management. The CPM provides accurate, timely and accessible information to customers and stakeholders on the Clinical Development Plan (CDP) and its studies from early clinical development through to late stage development and life cycle management.
1. CONTRIBUTES TO CLINICAL DEVELOPMENT PLAN (CDP)
• Supports GCL/ECL in in the preparation of the operational aspects of the CDP and its studies by developing scenarios for study designs, timelines, budget and quality
• Provides input to the clinical section of the target product profile (TPP) as needed
• Guides and oversees the goal setting process for the CDP in close collaboration with study team and all clinical team members
2. PLANS RESOURCES (FINANCIAL, FTE) AND TIMELINES FOR CDP
• Generates and analyzes scenarios for development pathways with timelines, cost and FTEs.
• Provides cost overviews with cost for each study in the CDP, supported by the Resource Management and System Integration (RMSI) group
• Provides FTE estimates for each study in the CDP supported by the RMSI group
• Reviews & approves the detailed study timelines, budgets, country allocation and resource needs after feasibility has been finalized
• Supports alignment with collaboration partner regarding resources and timelines
• Facilitates outsourcing decision and CRO onboarding
3. TRACKS AND FORECASTS CDP COSTS AND RESOURCES
• Leads tracking & management of the implemented CDP and provides study actuals and estimates .
• Leads monthly reporting of project-level milestones, costs, resources and quality information to appropriate stakeholders, forums and governance groups
4. MANAGES RISK AND CHANGES FOR CDP
• Leads tracking and troubleshooting of operational activities at the CDP level
• Supports accurate tracking and forecasting of study resource (Costs and FTE)
• Collaborates with stakeholders such as GCLs, ECLs, study and project teams and key functions to identify issues/risks and to provide timely issue resolution
• Provides accurate, timely, and accessible information on issues and issue resolution to all stakeholders
• Provides timely updates on key changes to planned studies to all involved functions
• Assess costs and resourcing (FTE) impact of changes in scope and timelines
5. COORDINATE STUDIES IN CDP
• Responsible for coordinating activities and communication across studies in the clinical development project.
6. PREPARATION OF DOCUMENTS FOR CDP AND STUDIES
• Leads and contributes to project level documents e.g. investigator brochures, clinical sections of CTD submissions, safety related documents.
• Contributes and has oversight of key study level document preparation e.g. study concepts, protocols/amendments and clinical study reports
• Co-ordinates and leads alignment of study documents across the CDP where synergies are possible and alignment is mandatory
7. MEETING ATTENDANCE
• Ensures regular global clinical team (GCT) meetings lead in conjunction with the GCL/ECL occur on a regular basis with the appropriate participants, including proper documentation
• Actively participates and presents in meetings as required e.g. GCT sub-team meetings, global program team (GPT) meetings, GPT subteam meetings, clinical project review meeting (CPRM), joint development team meetings, submission team meetings
• Supports GPT, in preparation of presentations for internal governance process (e.g. for GPDC, TDAC, ODC, OGC), providing budget, resource and timelines for CDP and studies
8. OPERATIONAL INPUT
• Initiates, leads and contributes to adjustable study planning, standards/COS workbook and the project plan (gantt chart)
• Liases with global medical affaires, regulatory and local functions to collect information on mandatory countries and patient numbers per country
• Initiates feasibility process, leads early indication feasibility and gives input to all stages of feasibility process including country selection
• Arranges bulk clinical drug supply for CDP with clinical supplies group (CSM) and GCL/ECL. Liases with CSM group and provides information on planned studies in the CDP, on CDP changes. Supervises information exchange between study teams and CSM on study status
• Contributes to the selection of external providers including CROs
• Maintains a high degree of awareness of the external environment and ensures external innovations in operational delivery are applied to studies
9. SYSTEM MAINTENANCE AND CONTINUOUS IMPROVEMENT
• Accountable for entry and maintenance of planned/concept studies in the clinical development plan in IMPACT
• Validates inputs/information required for Clinical Project Management (CPM) organization. Facilitates continuous improvement process in clinical development
• Evaluates internal and external benchmarking data on study timelines, resources and costs
• Chairs or participates in expert working groups, project standard teams etc.
10. ADDITIONAL TASKS – STUDY OPERATIONS
• May act as an oversight manager depending on the phase of the study.
• Master of Science with a minimum of 6 years of pharmaceutical Industry experience or Bachelor of Science or equivalent, with a minimum of 8 years of pharmaceutical industry experience
• Alternatively, equivalent length of Drug Development Project Management experience with 10 years Pharmaceutical Industry experience
• A minimum of 5 years of Pharmaceutical Clinical Operations experience is desirable including direct monitoring and clinical trial/study management experience
• Proven track-record leading the initiation and completion of studies and/or project
• In-depth knowledge of the drug development and commercialization process (from protocol writing in study management to medical results reporting and submissions)
• In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Committee for Harmonization (ICH) regulations)
• Knowledge in both existing drugs and new fields of exploration in one disease or therapeutic Area
• Proven people management expertise
• Familiarity with key clinical development systems Personal/People Skills
• Ability to effectively influence without hierarchical authority
• Willingness to embrace change and be able to work in a changing environment
• Strong communication skills to ensure that clinical development plans and status are transparent, and that risks, issues, and results are clear to all involved parties.
• Skills in: gathering information for decision-making; negotiation; and communicating decisions and actions
• Able to execute responsibilities with knowledge, accuracy, persistence, resilience and creativity
• Able to work both independently and collaboratively across cultures and geographies
• Able to work with a virtual team
Experience : 8 - 12 Years
Qualification : M.Sc, B.Sc
Location : Thane
Industry Type : Pharma
Functional Area : Clinical Project
Last date : 30th May, 2020
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