Reporting to the Head of Clinical Operations, this person will be responsible for leading a CRA team in the country, to ensure completion of high quality site management activities, enabling the delivery of clinical trials in the shortest possible time in accordance with the Company’s policies and procedures, SOP’s, local legislation and GCP requirements
Key Accountabilities: Clinical trial delivery •Ensuring a proper country allocation of projects, liaising with Global Trial Allocation •Ensuring the conduct of trials takes account of any changes in regulations and Company objectives, overseeing the projects in the respective therapeutic area •Resource planning to ensure site management of high quality, on time and within budget •Performing trial portfolio review process with Medical department •Working with other CRMs in the CDC and adjacent affiliate clinical managers to ensure consistency
Functional accountabilities and people management •Lead and develop his/her team ensuring a high-performance mind-set and results of both individual and team through NNWay of Coaching •Tailor development to team members with a tailored approach to develop others through coaching, feedback, exposure and stretch assignments •Line management of assigned team, including recruitment, training, development, compensation and performance management •Membership of, and effective contribution to, the Clinical Management Team •Represent Novo Nordisk at relevant conferences, meetings and events and involvement in cross-functional.
Purpose and subject of interaction with internal/external key contacts •Collaborating with all relevant stakeholders to ensure effective placement of studies and sharing of customer information •Collaborating across CDC and CMR, in particular with other Clinical Research Managers, Medical team and Data Management to ensure clinical trial delivery •Developing strong working relations with CDC and other adjacent affiliates to ensure information and knowledge sharing •Making an effective contribution to the CDC clinical research management team and project groups •Approximately 70% of interactions are with internal customers (CDC roles, Clinical Research team, Medical Affairs, Regulatory, P&O, Finance, Legal and Quality ) and the rest with external ones (Investigators and site staff, External suppliers and industry groups)
Challenges in regards to innovation and change. •Anticipate and embrace change implementation and adapt to circumstances effectively following business needs & strategy •Ensuring the CRAs are pro-active in identifying and adapting to changes in site management •Manage oneself leadership in order to maximize region results
Compliance. •Ensuring all aspects of clinical trials, including patient recruitment, patient retention, monitoring, data collection and documentation are conducted professionally and to a high standard, in accordance with Novo Nordisk’s policies and procedures, external regulations and good clinical practices •Maintaining current knowledge of SOPs and relevant legislation •Handling clinical non-conformities according to S
Requisitos del candidato
Más de 5 años
Knowledge & Experience.
Education requirements •Life sciences degree, ideally with a post graduate qualification in research •Fluent in Spanish and English
Work experience At least 5 years of pharmaceutical industry experience in a position related to Clinical Operations Wide experience in team management