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Job Details

Study Start Up (SSU) Manager (Europe) - Novella Clinical

Company: Novella Clinical Resourcing
Location: Homebased
Reference: NC_SSUMan_EU
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Dependent on Location

Job Summary:

A new and pivotal position within the European operation as we look to streamline the start up process and introduce the Study Start-Up department. This will be a first time hire for this department and we are looking for people based across the EU, primarily interested in professionals in Italy, UK, Spain, Germany, France or Belgium. Experience in Study-Up for local/EU Clinical trials including Quality Assurance, Regulatory Submissions related to Study Start Up.


Novella Clinical is looking for an experienced Clinical Study Start-up Manager to join our head up our new Study Start-Up Unit in the EU. The Study Start-up Manager are responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes the overall management and oversight of the following processes: site feasibility, regulatory approval, and site contracts.  May be assigned to manage the site start-up activities for a country, region, or entire global trial.

The SSU Manager also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position works directly with Director of Clinical Monitoring, VP Operations, Project Managers and Clinical Trial Managers in setting priorities for study start up.  This individual works with the VP of Operations to set forward looking strategy for the Department as it strives to meet its internal objectives to support overall Novella top and bottom line performance.

This is a new and pivotal position within the European operation as we look to streamline the start-up process and introduce the Study Start up department. This will be a first time hire for this department and we are looking for people based across the EU, primarily interested in professionals in Italy, Spain, Germany, France or Belgium. Although being office based in our Steveange office would be a benefit.

Key Skills & Responsibilities:

  • Serve as SSU Manager within region for project(s) or programs or service line. Lead SSU team or service line in all the activities. Monitor team efficiency, quality and adherence to project timelines, budget , SOPs and WPs.
  • Develops, with the input of regulatory and contracts, a study specific SSU plan.
  • Communicates overall site activation status to project manager and Client
  • Directs the process for the selection of study sites and investigators.  Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
  • Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.
  • Where applicable, provide work instructions to team members in preparation of regulatory submissions.
  • Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.
  • Facilitates communication within the clinical team (e.g. SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met.
  • Works with SSU Leadership team to implement QC/QA processes that are effective in providing high quality deliverables to our internal and external teams.
  • Directs the development of study start up Review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP).  Works with SSU Leadership Team to implement processes that assures compliance.

If you would like to discuss this role and department in more detail I would be pleased to receive your CV and set up a call to go over the details. This is a great opportunity to join a new department and make a huge impact in the direction and service provision of Novella Clinical.

Please feel free to get in touch via email or phone to discuss this further (

Apply for this job: Study Start Up (SSU) Manager (Europe) - Novella Clinical

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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