Study Start Up Manager 9SSUM) - Poland

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy, expectations and parameters for submissions and all necessary authorizations.
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy and expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers.
• Deliver presentations and training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree in Life Sciences or related field.
• 7 years of relevant experience in a scientific or clinical environment, including demonstrable experience in an international role.
• Equivalent combination of education, training and experience.
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
• Demonstrated proficiency in using systems and technology to achieve work objectives.
• Good regulatory and/or technical writing skills.
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
• Good leadership skills, with ability to motivate, coach and mentor.
• Ability to exercise independent judgment taking calculated risks when making decisions.
• Excellent understanding of study financial management.
• Proven ability to work on multiple projects balancing competing priorities.

Compensation and Benefits

• The potential base pay range for this role, when annualized, is 201, 500 PLN – 374, 100 PLN. The actual base pay offered may vary based on a number of factors.
• Dependent on the position offered, incentive plans, bonuses and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
• Employee Referral Payment Standard Referral Bonus Plan.