Study Start Up Senior Manager - Poland - FSP

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us atSite Start UpSenior Manager, home-based and sponsor dedicated, in Poland.

In this role you will oversee a portfolio of sponsor´s studies where the sponsor have given operational responsibility to our CRO partners for trial execution.As an expanding capability the Senior Manager, Site start Up will support development of infrastructure, processes, teams and appropriate technology to assist in the effective oversight of out- sourced studies.Additionally, this role will work collaboratively with the CRO project teams to maintain timelines and ensure that start-up activity is progressing as expected per the startup plan.

We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.

You will work from your 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.

The most significant aspect of this position is

• Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation. 
• Laser focus approach to oversight of startup activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.
• Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively to CRO counterpart and Jazz colleagues (e.g., CTM) as required.
• Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners
• Leads day to day project activities in the matrix, by working closely with the Jazz Clinical Trial Manager and CRO counterparts.
• Oversees start up activities with one or more CRO partners at a program and/or study level.
• Acting as a Senior Manager with regional colleagues co-ordinate regional information to present based on oversight of regional colleagues (if required) depending on size of study/complexity.
• Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan
• Specialist knowledge of start-up requirements & activities in each country and region, country requirements, inner workings of a country/ regulatory landscape. 
• Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Legal, Contracts and Clinical Operations
• Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout
• Reviews and approves start up plan(s) that clarify study specific tasks, general timelines, and processes related to overall study start up.
• Liaise with other project team members to ensure cohesive and clear project performance and expectation
  

From you we expect

• Degree (BSc) or equivalent experience gained through time in industry (>5yrs).

• Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials (minimum +5 years). 

• Experience in project management, CRO experience, change management or process design are beneficial

• The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.

• Excellent knowledge of GCP and regulations

• Experience of controlled drug substances processed would be beneficial

• Experience of developing junior members of staff would be beneficial

• Experience of Regulatory Inspections

• Demonstrates ability to analyze complex situations, develop comprehensive plans, and oversee their execution across multiple partners and regions.

• Excels in building and maintaining productive relationships with diverse teams and stakeholders, both internal and external.

• Applies expertise to define scope, set timelines, monitor progress, and solve challenges in complex, multi-faceted projects.

• Exhibits strong ability to lead in a matrix environment, communicate effectively at all levels, and present complex information to various stakeholders.

For an immediate interview, please contact marta.kuniewicz@parexel.com