DescriptionLOCAL TRIAL MANGERWe are looking for a driven Local Trial Manager (LTM) to report to the Clinical Research Manager (CRM), running assigned clinical trials (phases 1-4) within theassigned TAthat will be decided based on workload distribution.
You will have operational oversight of assigned protocols from start-up through to database lock/ closure of the trial.
You will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.The LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM) roles.
The LTM may have some site management responsibilities.
You need a flexible mindset and have the ability to work in a fast-changing environment.
You will be part of a hardworking, enthusiastic, and committed team of +100 people eager to deliver and helping to improve the lives of millions of patients.Principal Responsibilities: Collaborate with the CRM for protocol and site feasibility assessment.
Implement consistent pre-trial assessment visit approach.
Set predictable and realistic start up time lines.Lead and coordinate local trial activities and project planning activities to meet site open and recruitment targets and to deliver high quality data on time and within study budget.
Develop and install contingency plans in a proactive way and drive issue resolution in a timely matter.Act as subject matter expert for assigned protocols.
Develop strong therapeutic knowledge.
Act as primary country contact for a trial.
Establishes and maintains excellent working relationships with external organisations and internal partners, including Medical Affairs.
Review and approve monitoring reports.
Prepare country specific informed consent forms.
Obtain country Ethics Committee and Health Authority approvals.
Keep oversight or initiate of corrective and preventive actions.Encourage and empower trial teams to deliver on the trial commitments.
Keep patient engagement and safety central to all activities.
Contribute and encourage process improvement at every opportunity.
QualificationsDo you have the following Education and Experience we require?
: A minimum of a BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
You have gained experience in clinical trials and preferably in site monitoring and have experience of project management tasks.
Ability to travel with occasional overnight stay away from home.
You have proven leadership skills, effective communication skills and digital literacy.
The ability to lead initiatives/small teams.
Proficient in local language(s) and EnglishBenefits:We offer a competitive salary and extensive benefits package.
The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance.
We offer career development opportunities for those who want to grow and be part of our organization.
We are Janssen!Johnson Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.Job Field: Clinical Trial Project ManagementOrganization: Janssen-Cilag S.p.A. (7175)
