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Manager, Clinical Trial Management Business Support Job

Eingestellt von Bio Careers

Gesuchte Skills: Support

Projektbeschreibung

Requisition ID 13170BR
Title Manager, Clinical Trial Management Business Support
Job Category Clinical
Job Description PURPOSE:
Responsible for the management and deployment of insourced staff within USA in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for operational aspects of planning and management of performance in accordance with departmental productivity expectations. Close collaboration with other managers and with various functional units of Clinical Trial Management (CTM) department.

RELATIONSHIPS:
Reports to the Associate Director Clinical Trial Management Business Support within Clinical Trial Management (CTM). Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of all functional and departmental milestones. Effectively manages to the direction and strategy for in sourced staff performance, provided by the insource partner, within clinical trials at NNI thereby facilitating the CTM department to effectively manage all its business deliverables. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

CORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
• As a CTM Manager ensure that all personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
• As a CTM Manager responsible for the coaching, development and growth leading directly to improvement of talents of the personnel within CTM to meet increasing levels of responsibility.
• Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
• Ensure that insourced personnel understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted.

DEPARTMENTAL MANAGEMENT AND STAFF DEVELOPMENT:
• Active mentorship of CTM staff to build talent across the department.
• Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management of self and instill in all staff across CTM department.

FUNCTIONAL MANAGEMENT/SUPPORT:
• Accountable for ensuring that the insourced partner assures the quality of their employee performance and thereby responsible for the quality of insourced performance within CTM.
• Cross team membership, coordination and motivation of the region across NNI.
• Implements and may participate in continuous improvement processes for function.
• Active membership to local management teams.
• Direct oversight of the staff appointed by the insource vendor partner including training, hiring, discipline, and terminations for them.
• May contribute to input and maintain guidelines, training programs, policies and procedures for the functional locally.
• May identify training gaps within function, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
• May provide input, support and communicate functional, departmental or organizational initiatives.
• Responsible for the implementation and ensure execution of strategies are actively employed by the insource vendor partner to meet corporate or local goals or directives.
• Responsible for ensuring proactive management of insourced staff to collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively as required based on impact at the core business. As a CTM Manager providing guidance and oversight to junior staff on communication of such.
• Accountable for all timelines and effective resource deployment of assigned insourced staff. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance for the assigned insourced staff and ensures this is integrated into the overall plan for the monitoring management functional and departmental CTM business deliverables plan.
• Accountable for delivery of the productivity metrics for the insourcing partner. For those in role supporting insourced CRA staff trip report completion within the assigned timeframes and to the expectations of CTM and oversight visits to assure compliance with CTM expectations, GCP and Novo Nordisk SOPs.
• Accountable for ensuring any project transitions are completed in a timely fashion and that the documentation to support that transition is completed.

RESOURCE ALLOCATION:
• Responsible for the assessment and allocation of resources for the region and reviews utilization data on a weekly basis to adjust and manage deployment proactively and effectively.

TEAM COORDINATION:
• Implements cross departmental work, locally, and communications for assigned as per the clinical development plans.
• Implements work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
• Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure.
• Responsible for ensuring that the mandatory trial entries are made in IMPACT, NovoDOCs, mynovotrial.com, EDC administration and updates are made.
• Responsible for maintaining focus, locally, for specific department activities within CMR priorities.
• Attend relevant symposia, conferences and scientific meetings, as necessary.
• Provide support and potential identification of training needs across CTM and direct the creation, development and potentially provide training support to meet those needs.

DEVELOPMENT OF PEOPLE:
• Active mentorship of CTM staff to build talent across the department.
• As a CTM Manager ensure staff are actively developed in the accordance with the departmental expectations.
• May develop and maintain guidelines, training programs, policies and procedures for the functional locally.
• May identify training gaps within region/function, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
Additional Information PHYSICAL REQUIREMENTS:
• Office based position in Princeton, NJ.
• 10% travel required.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelors' degree (in science area preferred) or registered nurse, (4 year degree). Advanced degree preferred.
• 12 months of site monitoring experience.
• Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.
• At least a Minimum of 7 years of clinical trial experience within pharmaceutical and/or healthcare setting. 5 years within a pharmaceutical, biotechnology or CRO where the previous roles were directly related to clinical trial execution is preferred.
• Demonstrated computer skills (MS Office, MS Project, PowerPoint).
• Knowledge of GCP as relates to clinical trial management.
Department CMR - FIELD MGMT - BUSINESS SPPRT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%

Projektdetails

  • Einsatzort:

    Princeton, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Bio Careers