Local Study Associate Director (Clinical Operations Leader) - Poland - FSP
Poland, Remote Job ID R0000027553 Category Clinical TrialsAbout this Role
Parexel is currently seeking a Local Study Associate Director (Clinical Operations Leader) to join us in Poland. You will be assigned to one of our key sponsors in the region.
Working as a Local Study Associate Director (LSAD) 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.
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.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
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