Local Study Manager/Associate Director - Remote
United Kingdom, Remote Job ID R0000030239 Category Clinical TrialsAbout this Role
Parexel is currently seeking a local study associate director to join us in the UK, you be assigned to one of our key sponsors in the region.
Working as a Local Study Associate Director at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.
Our LSAD's work from their home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Some specifics about this advertised role
Dedicated to one client.
Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports.
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
Here are a few requirements specific to this advertised role.
Ideally an advanced degree - BSc, MSc or PhD
Minimum of 3 years' experience running local clinical trials.
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Experience in, and willingness to monitor oncology clinical trials - if needed based on flexible capacity.
Experience performing submissions to RA and EC
Experience partnering with study functions to ensure smooth delivery.
Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
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