- Title: Evidence Delivery Manager
- Code: RCI-20327
- Location: Gaithersburg, MD 20878
- Posted Date: 10/13/2021
- Duration: 12 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
Candiadte must be 100% Onsite Gaithersburg, MD.
- BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on Company therapies and support our internal stakeholders with medical insight and expertise.
- BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products.
- BPM aims to lead Company in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
- The BioPharmaceuticals Medical Evidence organization is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on Company therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.
- Evidence Delivery Managers (EDM) will lead or support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research.
- They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).
- The EDM may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.
- In addition, the EDM will support BPM Evidence’s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
Usually, the EDM’s focus will be on one of the three main types of work as described below.
Specific activities/responsibilities per type of study:
Company Sponsored Observational and Interventional Research:
- Support/coordinate protocol development and finalization
- Manage Study Governance (post SDC)
- Support/coordinate all internal, study governance processes (e.g. MEORT, MARC, LSPC, Clinical Challenge)
- External Service Provider Management
- Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
- Support strategic handover meetings and kick off meetings
- Perform CRO oversight to help ensure project delivery within time, cost and quality
- Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery
- Manage study specific issues and escalations with ESPs/CROs
- Stakeholder Management
- Support Project team set-up and study sourcing activities
- Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles
- Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Delivery Associate Director(EDAD))
- Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local Company and External Service Providers
- Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery
Manage study finance:
- If leading a study, develop and maintain the overall study budget (internal and external study costs)
- Ensure transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
- Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
- Manage and reconcile Contracts, POs and invoices
- Support financial audit readiness and Sox attestation as needed
- Other Project Management activities as applicable
- Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to Company quality standards
- Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
- Support implementation of study-related change management within business strategy, s.a. assessment of scope changes
- Ensure Compliance with Company Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
- Undertake feasibility assessments with internal and external stakeholders
- Manage study systems reporting
Externally Sponsored Scientific Research (ESR):
- Supports the review of ESR proposals and protocols to enable a consistent, high quality approach to evaluation
- Manage across a range of global and local cross-functional stakeholders to ensure all Company obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met
- Manage external stakeholder, e.g. external Investigator and Sponsoring institutions
- Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals)
- Provide oversight to local Marketing Companies (MC’s) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate
- Lead and manage aspects of the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research projects
- Acts as the first point of contact for local MC operational enquiries
- Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. In doing so, guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met
- Ensure operational quality and compliance with policies and procedures for ESRs globally
Early Access (EA) /Named Patient Supplies (NPS):
- Leads aspects of the planning, implementation and delivery of EA programmes
- Perform vendor oversight to ensure EA Program delivery to time, cost and quality
- Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery
- Manage triaging of program specific issues and escalations with internal (e.g. Global Clinical Leads, Chief Medical Office, supply chain representatives) and external stakeholders
- Manage the review process of NPS requests to ensure timelines for decision making are adhered to, utilising appropriate Company systems, so that a decision on the request can be returned to the patient’s physician
Independent of the study type, key accountabilities of the Evidence Delivery Manager are:
- Management of study Governance processes
- Management of internal and external stakeholders
- Finance Management support
- Project Management of owned study areas to deliver according to cost, time and quality
- Support of study Risk Management and Quality Management activities
- Study compliance
Note additional accountabilities around finance management and team resource management may be relevant when assuming a study leadership role.
Education, Qualifications and Experience
- Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
- Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
- Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
- Scientific awareness and extensive knowledge of observational study guidelines and SOPs
- Extensive knowledge of early and late stage Pharmaceutical Development
- Ability to effectively work with Clinical Research Organisations/External Providers.
- Proven ability to interact widely and effectively within the company across regions, functions and cultures.
- Experience and knowledge within compliant management of Externally Sponsored Scientific Research
- Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
- Open to periods of travel