Global Study Start Up Manager

Company Description

Ergomed is a rapidly growing global clinical research company. We perform clinical trials for rare and complex diseases.

Ergomed Plc is a public company on the London stock exchange.

The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.

Job Description

Due to continued growth of our Global Study Start Up Group we are seeking a Study Start Up Manager.

The Global Study Start Up Manager will be responsible for (but not limited to) the following activities :

• Collaborates with major functional area leads (e.g.: Feasibility, Site Contracts and Legal, Regulatory Affairs, Study Start Up Specialists, Site Managers, Clinical Operations) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.
• Develops and maintains strategic relationships with customers in alignment with their assigned projects.
• Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
• Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
• Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
• Reviews the project SSU budget and scope of work with the project PM against project milestones and budget to ensure project profitability. Pro-actively discusses corrective measures with the project PM where necessary to keep project in line with budget and gross profit expectations.
• Accountable for the negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines in close collaboration with the Site Contracts Manager.

* Please note this position can be offered in any of our European locations

Qualifications

• Bachelor’s Degree (or equivalent) in Life Sciences.
• Demonstrative CRO industry experience with specific experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
• Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
• Understanding of the specific country requirements pertaining to Site Activation delivery in in one or more regions (but at least in the country of residence) and the ability to work across geographic regions.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Excellent communication, presentation and interpersonal skills.
• Ability to mentor and coach lesser experienced staff and supports SSU Management on all administrative or departmental activities.
• Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet.

Additional Information

All your information will be kept confidential according to EEO guidelines.

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.