Clinical Operations Manager (H/M) - [U-333]

Clinical Operations Manager (H/M) - [U-333]

21 mar
Importante empresa

21 mar

Importante empresa


Descripción de la oferta

Project management:Control the Clinical Research Management System (example Global Study Tracker: GST).

Supervise the start-up, execution and follow-up of clinical studies and assure the studies are performed with high quality standards and within the expected timings and budgets.

Lead and supervise the team assigned to each clinical study and the related professionals (BBRC team, external providers, CRA, Auditors, etc.) in order to control and resolve any possible issues.

Prepare and distribute studies status reports (recruitment, timing, costs. etc.)

Act as the contact person with Regulatory Authorities, CROS, pharmaceutical companies, suppliers, providers,

subcontracted institutions and others stakeholders.

Guarantee the inclusion of the participants agreed for the different studies with BBRC, Pharma's o CROS and control the specific selection strategy needed for each study.

Clinical studies: Observational studies and clinical trialsEstablish the project flowchart, assuring the correct and most efficient assignment of human, technological and economic resources and their corresponding cost.

Develop strategic initiatives to improve the efficiency of the Clinical Operations Office.

Assure the correct execution of clinical research operations (BBRC own studies, European research or clinical trials), developing all the project phases in accordance with guidelines and logistic needs, including material, essential documents, costs of operations, and activities planning (initiation, execution and closure) of clinical projects.

Review protocols (from the BBRC Research Management Office, CROs, etc.) and coordinate the adequate submission to Ethic Committee and Regulatory Agencies for their approval.

Guarantee the integrity of Trial Master File (TMF) of each clinical research study.

Safety and qualityControl the creation, implementation, follow-up and maintenance of internal processes and guidelines of the Clinical Operations Office.

Assure adherence to GCPs, internal guidelines and legislation requests.

Maintain the standards of quality at any steps of clinical projects.

Guarantee preparation and assure the correct realization of audits and inspections. Coordinate the resolution of findings.

Control safety procedures for study participants following the highest standards requested in clinical research.

Costs Coordination and BudgetingElaboration Clinical Operations Budgets and costs tracking (Visits/Studies costs, Investigator fees, office infrastructure budgeting and costs control, etc.).

Contact person for BBRC clinical research fees negotiations with Industry, CROs and providers.

Control the process of conciliation of derivative bills of the payments of the clinical assays.

Team ManagementAttract and retain the talent, reducing the rotation and increasing the sentiment of belonging.

Promote maximum motivation and efficiency among the professionals (individual interviews, constructive feed-back, training selection, etc.). Distribute and control the tasks and dedications of professionals.

Perfil Buscado (Hombre/Mujer)

University degree in health science-related.

5 years' experience in clinical trials, Clinical Research in Hospitals, CROs o Pharmaindustry.

Proved experience in team management (>15-20 people).

Valuable training or Master in Clinical Research Management.

Fluent in Catalan, Spanish and English (Proficiency Level-written and spoken).

Advanced level in Word Office suite.

Effective Oral and Written quality communication skills.

Strong organizational skills: ability to plan objectives and strategies, which allow team members to perform optimally. Must be able to put systems in place that maintain order and guide team members toward the institution objectives.

Should demonstrate integrity values and must possess effective interpersonal skills, be respectful and able to empower team members.

Demonstrated ability in decision-making process, solving problems and reach objectives.

Ability to think independently and work collaboratively (empathic and focused teamworker)

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