Sr. Specialist - Roma, Italia - MSD

MSD
MSD
Azienda verificata
Roma, Italia

1 settimana fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Job Description:

Primarily serving as a key communication point between GCTO identified Clinical Research institutions, study investigators and their teams, country clinical operations, & regional and head quarter functions, to support the delivery of our company clinical research portfolio following late-stage development process through positive, transparent and systematic
communication and coaching.


Using a metric driven approach and agreed GCTO objectives, supports and co-ordinates the management of clinical sites, in close collaboration with other members of the GCTO and GCD team.

Uses expert knowledge of systems and processes while supporting and innovating through the available tools and resources, locally or through global initiatives.


The role serves as a key internal and external facilitator and coach to represent the company to support the delivery of clinical studies at specified clinical research sites.

Specific sites should be identified through metrics and operational and scientific need. Institutional support is agreed by the country and/or global functions and the identified site.


The post holder will lead regular meetings with sites to review agreed institutional study related metrics to proactively facilitate study delivery and identify "systemic" issues and opportunities.

Support the negotiation, agreement and maintenance of associated contracts and budgets with the institution, if appropriate, and have oversight of the institutional clinical
research landscape.

Working as part of the local country GCTO leadership team the role will help develop and implement strategic and operational approaches to enable and facilitate country level implementation of key initiatives impacting sites, supporting communication, interpretation and appreciation of key metrics to assess partner site collaborations and serves as an interface with internal global site networks and external site forums/professional societies as
appropriate in the country / territory.


Successful execution of company trials across all therapeutic areas, building professional, productive and positive relationships, placing our company as a partner of choice among our key sites.

Strategically supports initiatives with a solution
- oriented focus to coach and overcome challenges with sites and innovation with local GCTO and GCD partners.


Responsibilities include, but are not limited to:

  • As a member of local country leadership team, establishes and fosters effective relationships with internal and external stakeholders, and pre-identified institutions with clinical operations capabilities in order to deliver clinical studies / programs.
  • Effectively communicates with sites in support of pipeline planning and delivery, regulatory and ethical documentation,financial payments, and contracts
  • Provides exceptional customer service, facilitating decision making between key institutions and our company through the use of company metrics and acquired institution knowledge and expertise
  • Collaborates with internal stakeholders, across GCTO and the wider GCD division as per study and portfolio need
  • Supports pipeline related investigator meetings and associated planning, delivery and followup
  • Collaborates with internal stakeholders & actively participates in country strategy for upcoming programs as needed
  • Coaches and supports GCTO country teams in development of therapy area institutional intelligence and early site validations at preidentified key institutions
  • Supports identification and targeted site selection based on metrics and portfolio needs
  • Systematically share and discuss future studies and review portfolio with preidentified key institutions regularly
  • Proactively supports site initiation activities and remediation, as appropriate in conjunction with internal stakeholders using expert site knowledge and company metrics
  • Identifies, assesses, and resolves any systemic institutional site management issues, throughout all study phases through use of metrics and expert knowledge
  • Supports continuity of innovation and organizational initiatives, including new company technologies and systems in relation to site management and study delivery
  • Proactively acquires and shares knowledge and understanding

Qualifications

Education and Minimum Requirements:

Bachelor's Degree (or higher) in a relevant scientific area or equivalent Health Care related experience


Required Experience:


  • 5+ years of experience in Clinical Research
  • Previous project management / Senior CRA experience preferred

Skills:


  • Demonstrated ability to work independently and in a team environment
  • Possess strong knowledge of local regulatory and compliance requirements
  • Knowledge of and continuous development of institution/organization operational
structures

  • Excellent time management, project management, organizational, issue identification,
problem-solving, and communication (written and verbal) skills

  • Demo
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