Covance

Clinical Project Manager (Sponsor dedicated)

Company
Covance
Location
Zollikon, Switzerland
Salary
Competitive
Posted
20 Sep 2019
Closes
20 Oct 2019
Ref
36270
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Covance is searching for a Clinical Project Manager, to be office based by the sponsor in Lausanne.

Main responsibilities
  • Project Team:

  • He/she is amember of the project team and works in a collaborative and proactive way with all team members. Within the matrix organization, s/he plans all the multidisciplinary activities related to his/her own deliverables, provides the Global Project Leader with the appropriate information, and alerts him/ her in case of deviations and risks. He/ she makes sure that his line manager is aligned with the deliverables, and he/ she commits to delivering them in time, quality and cost.

    He/she will participate to the Project team meetings to represent Clinical Operations on request only.
  • Study team leadership.
    • Leads (matrix management) the cross functional study team dedicated to the clinical study, and manages the external vendors (CROs), while adequately escalating issues, planning and controlling the allocation of resources (incl. CROs), ensuring the appropriate training to the study team members.
    • Reports clinical study progression-status adequately, and communicates immediately to the Global Project Leader and Line Management any deviance from the pre-established baseline (costs/timelines).
    • May have Operational and/or Line management responsibilities.
  • Study timelines (from feasibility to DB Lock)
    • Responsible and accountable for the overall planning and timelines of the study. Pro-actively anticipates, prevents or takes appropriate action to correct the identified delay or bottlenecks. Develops, manages and maintains study timelines (MS Project) for the clinical study and integrates the deliverable dates from the other Medical Affairs functions (e.g. PK. PD, personalized medicine) and CMC.
  • Study budget
    • Responsible for the management of the clinical study budget:
    • Sets up the overall clinical study budget (including consolidated figures provided by CMC and the other CR&D functions e.g. PK. PD, personalized medicine). Of note CTMs are only responsible and accountable for the ClinOps part of the budget.
    • Participates to the preparation of Request for proposal (RFP), in collaboration with the Outsourcing Manager, and finalize Summary of Work and Work orders.
    • Develops and monitors investigative site/CRO budgets, oversee negotiation of financial terms, and drives site/CRO contracts execution. Manage site/CRO invoices and payments
    • Responsible to inform Management and PMO of any change to pre-established baseline.
    • Propose budget modifications, if needed and justified, to the Management and Global project Leader
    • Study close out: Reconcile payments and study budget.
  • Study quality
    • Responsible and accountable for the quality of all activities and key steps of the clinical study deliverables, and the delivery of the clinical study according the ICH GCP and local applicable regulations, and in accordance with company's SOPs/WPs.
  • Study communication, progress and updates
    • Responsible and accountable to schedule and lead appropriate Meetings/TCs such as:
    • CRA meetings/TCs.
    • Study team meetings: Prepares agendas before internal study team meetings, and makes sure that relevant study team members attend. Leads the meetings. Responsible for the study team meeting minutes finalisation within 48 hours.
    • CRO meetings/TCs: reviews the Agenda upfront, and makes sure that relevant study team members are invited and attend. Makes sure that the CRO meeting/TC minutes are finalised within 48 hours, and adequately distributed to the study team members.
    • Manages the CROs and obtains clear and regular reports pertaining to study progression and status.
    • Internal Communication: Communicates the study progression (e.g. patient recruitment, progress reports, goals achieved, and overall timelines) within the company. Actively participates in the external communication (e.g. investigators TCs, investigator updates taking place during international conferences) with the Medical Directors. Responsible for the Newsletter finalisation.
  • Study Planning and Execution (from feasibility to DB Lock)
    • Responsible and accountable for Trial master File (TMF) set up, maintenance, and continuous QC.
    • Participate in Country selection; identify prospective investigative sites (in collaboration with the Medical Directors, monitor ICH GCP site compliance. Recommend number of investigative sites. Actively oversees the feasibility process. Oversees the development of drug supply forecasting and management.
    • Participates in CRO selection: Recommend vendors and review specifications for external vendors (e.g. Central labs). Management and oversight of external vendors.
    • Input in Protocol synopsis, Study protocol (regarding all operational aspects of clinical studies, e.g. study flow chart), Clinical Database, Safety, and CSR reports: Facilitate and review as appropriate summary reports, CSR, and appendices
    • Initiation and Study start up:Responsible for the preparation and review materials for Kick-off, Investigator meeting and CRA Trainings. Plans and conduct these meetings. Oversees the preparation of dossiers submitted to HA/ECs. Obtain country/site insurance certificate. Responsible for the CT.gov set up and go live.
    • Develops training materials and coordinate training on study procedures, develop study management plans and study specific working procedures (e.g. Study Operations Manual, Study Monitoring Plan, Communication plan, Project Management Plan, contingence plan \u2026).
    • Study Monitoring:Ensure enrolment is tracked appropriately, compile enrolment status, and address enrolment issues. Oversee review and approval of Monitoring visit reports and provides feedback accordingly. Ongoing review of data & listings collected in the eCRFs (e.g. Via CS Monitor) or ensures that the data review is done by house CRA or CRO. Ensures that ongoing data review is performed. Follow up on outstanding Edit queries. Responsible for answering to Audit reports. Responsible for the CS Monitor to be customized and implemented for each clinical study.
    • On request, may prepare tables, listings and summaries for Investigator TCs/ meetings.
    • Ensures that final clinical study report (CSR) is finalized within the pre-established timelines (MedDir is responsible for this task).
    • Study close out: Close out activities (Sites, CROs). Reconcile, QC and archive the TMF once CSR is Final.
    Education/Qualifications:
    • University degree or equivalent in Life Sciences
    Experience:
    Key Competencies, skills and knowledge required
    • Previous experience in clinical Study management (previous monitoring experience preferred), in the Pharmaceutical Industry or CRO
    • Advanced knowledge of: Drug development process and disease / therapeutic area; ICH GCP and local guidelines, regulations and directives, Financial budgeting and forecasting.Project management,Computer skills, mainly MS applications including MS project, Internet resources, study tools including electronic system skills- CTMS/EDC
    • Language skills: Fluency in English, French
    • Personality and Behaviours:

    oInterpersonal skills and Excellent communication skills

    oTeam spirit and ability to work in a matrix environment.

    oLeadership, dynamism and pro-activity, withcapability to coordinate a study team, and high sense of responsibility and initiative

    oPrecision and accuracy while keeping the global picture.

    oStrong time management and organisational skills to effectively prioritize and manage complex multi task operations,capable of anticipating obstacles and bottlenecks, acting as problem solver

    oCapable of dealing with the unknown, and to react with a sense of urgency

    oFlexibility and ability to adapt to a changing environment and to work under pressure

    oWillingness to share best practices with colleagues.Active contribution to process improvement initiatives.

    oWillingness to coach and mentor

    oWillingness to travel according to business needs


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