Requisition ID 13739BR
Title Senior Project Manager - Clinical Strategy
Job Category Medical
Job Description PURPOSE:
This is a project management role which streamlines communication and fosters ongoing collaboration between CTM, MA, and CDR to enhance the researcher and patient experiences through the Medical Associates Research Collaboration (MARC). Ultimately, this role will support efficiencies for the role of medical affairs in the Novo Nordisk clinical trials. In addition, the Senior Project Manager, Clinical Strategy will be responsible for the financial management of the overall US Medical Affairs budget including tracking and reporting.
RELATIONSHIPS:
This position reports directly to the Director, Medical Affairs – Clinical Strategy and has broad responsibility for managing multiple internal relationships within and across Novo Nordisk Inc. as well as with Global HQ. This position will liaise primarily with internal Medical Affairs, Field Medical Affairs personnel, Clinical Trial Management, Clinical Development, Global Medical and other functions. Additionally, this role will work in close collaboration with and utilize inputs from cost center Managers and key stakeholders involved in the budget and planning process, as well as partner with the US Finance group.
ESSENTIAL FUNCTIONS:
MARC ACTIVITIES:
• Central point of communication for internal support of Novo Nordisk sponsored trials. Partner and liaise with clinical trial management, field medical affairs, medical affairs, clinical development and research, and the global team to provide project support in various stages of trial lifecycles
• Develop and Maintain tracking reports for:
a. requests for study support
b. FMA involvement in study support, including all site assignment lists, key milestones and metrics
c. key major events across the development program
d. demonstrating the value of the collaboration
• Develop tools and training for MARC facilitators and field teams as necessary
• Coordination of and frequency of facilitator meetings/teleconferences and training
• Develop solutions to support MARC field teams
• Ongoing support of the MARC web portal
• Maintenance of MARC facilitator team mapping/roster/size/geographic coverage
BUDGET & CONTRACT COORDINATION:
• Ensure Medical Affairs budget is developed and managed in line with organizational expectation, including the development of appropriate project budgets
• Works with cost centers to facilitate the accrual process and meets with designated cost center/project owners to prepare month-end accruals journal entries.
• Analyzes financial data and monitors the execution of expenditures against the operating plan, partnering with cost center/project owners to make adjustments when necessary and ensure amounts and timing are current and accurate
• Validates projects against Statements of Work (SOW), contracts, and supporting documents to ensure funding levels, due dates, contract compliance and authorizations
• Ensures the validity of the data (planned, actual) within the financial systems (SAP and BW) and confirms project estimates are updated
• Prepares Project Summary reports and other ad hoc reports of Projects Planned, including Actual vs. Budget spend.
• Prepares BW/SAP queries, the Rolling Estimate (RE) and Anchor Budget (AB) process as required.
• Evaluates budget input and phasing for the reallocation of funds
• Coordinates the financial project planning process through direct interaction with supported project owners
• Assist department in meeting the balanced scorecard requirements by continuously monitoring the budget status.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree required; Degree in Accounting, Finance, or related field preferred. A minimum of 5 years financial analysis/reporting and accounting experience required. MBA and Pharmaceutical experience or experience in the healthcare or clinical trial environment is preferred.
• A minimum of 9 years in a project management role including Budgeting, Resource allocation/optimization experience.
• A minimum of 7 years’ experience understanding systems and requirements to set and measure cross-departmental functional deployment to meet corporate goals
• 5 years of clinical trial experience within pharmaceutical and/or healthcare setting is preferred.
• Knowledgeable of drug development and GCP principles as it relates to clinical trial management
• Analytical, negotiation, meeting management, cross-functional team and leadership skills required
• Project management and reporting experience with the ability to interact with various departments and levels internally.
• MS Office skills required with an advanced understanding of Excel. Knowledge of SAP ECC and BW preferred.
• Solid communications and relationship building capacity. Strong attention to detail and commitment to quality.
OTHER:
• Works within Novo Nordisk’s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
• Embraces Novo Nordisk Values in spirit and actions.
• Approximately 15% overnight travel
Department CMR - FMA CLINICAL STRATEGY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title Senior Project Manager - Clinical Strategy
Job Category Medical
Job Description PURPOSE:
This is a project management role which streamlines communication and fosters ongoing collaboration between CTM, MA, and CDR to enhance the researcher and patient experiences through the Medical Associates Research Collaboration (MARC). Ultimately, this role will support efficiencies for the role of medical affairs in the Novo Nordisk clinical trials. In addition, the Senior Project Manager, Clinical Strategy will be responsible for the financial management of the overall US Medical Affairs budget including tracking and reporting.
RELATIONSHIPS:
This position reports directly to the Director, Medical Affairs – Clinical Strategy and has broad responsibility for managing multiple internal relationships within and across Novo Nordisk Inc. as well as with Global HQ. This position will liaise primarily with internal Medical Affairs, Field Medical Affairs personnel, Clinical Trial Management, Clinical Development, Global Medical and other functions. Additionally, this role will work in close collaboration with and utilize inputs from cost center Managers and key stakeholders involved in the budget and planning process, as well as partner with the US Finance group.
ESSENTIAL FUNCTIONS:
MARC ACTIVITIES:
• Central point of communication for internal support of Novo Nordisk sponsored trials. Partner and liaise with clinical trial management, field medical affairs, medical affairs, clinical development and research, and the global team to provide project support in various stages of trial lifecycles
• Develop and Maintain tracking reports for:
a. requests for study support
b. FMA involvement in study support, including all site assignment lists, key milestones and metrics
c. key major events across the development program
d. demonstrating the value of the collaboration
• Develop tools and training for MARC facilitators and field teams as necessary
• Coordination of and frequency of facilitator meetings/teleconferences and training
• Develop solutions to support MARC field teams
• Ongoing support of the MARC web portal
• Maintenance of MARC facilitator team mapping/roster/size/geographic coverage
BUDGET & CONTRACT COORDINATION:
• Ensure Medical Affairs budget is developed and managed in line with organizational expectation, including the development of appropriate project budgets
• Works with cost centers to facilitate the accrual process and meets with designated cost center/project owners to prepare month-end accruals journal entries.
• Analyzes financial data and monitors the execution of expenditures against the operating plan, partnering with cost center/project owners to make adjustments when necessary and ensure amounts and timing are current and accurate
• Validates projects against Statements of Work (SOW), contracts, and supporting documents to ensure funding levels, due dates, contract compliance and authorizations
• Ensures the validity of the data (planned, actual) within the financial systems (SAP and BW) and confirms project estimates are updated
• Prepares Project Summary reports and other ad hoc reports of Projects Planned, including Actual vs. Budget spend.
• Prepares BW/SAP queries, the Rolling Estimate (RE) and Anchor Budget (AB) process as required.
• Evaluates budget input and phasing for the reallocation of funds
• Coordinates the financial project planning process through direct interaction with supported project owners
• Assist department in meeting the balanced scorecard requirements by continuously monitoring the budget status.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree required; Degree in Accounting, Finance, or related field preferred. A minimum of 5 years financial analysis/reporting and accounting experience required. MBA and Pharmaceutical experience or experience in the healthcare or clinical trial environment is preferred.
• A minimum of 9 years in a project management role including Budgeting, Resource allocation/optimization experience.
• A minimum of 7 years’ experience understanding systems and requirements to set and measure cross-departmental functional deployment to meet corporate goals
• 5 years of clinical trial experience within pharmaceutical and/or healthcare setting is preferred.
• Knowledgeable of drug development and GCP principles as it relates to clinical trial management
• Analytical, negotiation, meeting management, cross-functional team and leadership skills required
• Project management and reporting experience with the ability to interact with various departments and levels internally.
• MS Office skills required with an advanced understanding of Excel. Knowledge of SAP ECC and BW preferred.
• Solid communications and relationship building capacity. Strong attention to detail and commitment to quality.
OTHER:
• Works within Novo Nordisk’s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
• Embraces Novo Nordisk Values in spirit and actions.
• Approximately 15% overnight travel
Department CMR - FMA CLINICAL STRATEGY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%