Clinical Study Manager I

Description:

This position will be part of the Clinical Operations Team, which is responsible for executing, managing, and conducting projects associated with the company clinical study plans. The study manager manages, executes, and reports on clinical study operations; and provides support to members of the multidisciplinary project team, internally, and externally.

The Clinical Study Manager for International will be part of a small nimble group of Clinical professionals overseeing clinical trial management and commencement of new trials within the International / OUS (Outside US) region of Exact Sciences. This region encompasses Canada, Europe and Japan and also includes distribution markets across the globe.

This position is preferably office based at our International Headquarters in Zug, Switzerland. However we will also consider candidates based remotely in one of our affiliate International locations (DE, IT, FR, UK, IE, NL, SE).

The incumbent will work closely with third party vendor partners (CROs) and Clinical, Medical and other development function teams as needed, to help initiate and run clinical trials for new products.

Essential Duties

Include, but are not limited to, the following:

Act as a customer advocate throughout the project lifecycle.
Understand and support global project goals including site recruitment, patient recruitment, marketing, and public relations, as appropriate.
Implement approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies.
Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects; manage and execute the overall project scope and timelines.
Initiate and train sites to the study protocol; ensure proper site adherence to clinical research regulations.
Manage resources and timelines associated with all study start-up and implementation activities; including CRO/investigator agreements, central IRBs, and contractual agreements.
Support the management and oversight of CROs and other clinical study related vendors.
Plan for and manage all materials to support the appropriate execution of the clinical projects; including, but not limited to, distribution of documents, forms, supplies, equipment, and investigational device.
Ensure maintenance of document standardisation through the use of model documents, templates, and appropriate peer review.
Ensure the appropriate development of all documents by CROs; including, but not limited to, study documents (informed consent forms, case report forms, and instructions), site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
Ensure maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g., GCPs and company SOPs).
Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required.
Ensure operational and regulatory integrity of assigned studies and participates in EMA or other regulatory authority inspections, as needed.
Develop and maintain detailed timelines and resource projections for all programs.
Provide routine status reports and updates regarding the progress of programs.
Ensure that internal project team members are trained appropriately to ensure proper study conduct.
Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on the studies.
Manage the tasks that are not associated with in-life component of studies; including, but not limited to, development of database, statistical analysis, and report writing.
Prepare and review clinical data for analysis; manage relationships with consultants to provide adequate support and services for data collection and analysis. 
Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
Attend off site-meetings and conferences, as needed.
Ability to frequently and accurately communicate with employees, customers, and vendors in person, via telephone, or by email.
Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
Ability to manage multiple deadlines.
Excellent problem-solving and interpersonal skills. 
Have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
Excellent organisation and communication skills.
Strong desire to work in a fast-paced environment.
Ability to work independently and manage multiple timelines, while maintaining the team focus.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.

Minimum Qualifications:

Bachelor’s degree in the life sciences or a related field.
5+ years of experience as a Clinical Study Manager or in a similar role.
Experience leading project operational teams through the start-up, study conduct, data management, and report writing/review of clinical studies.
Experience writing, reviewing, and editing protocols and clinical study reports.
Experience dealing with decision makers; such as physicians, Ethics Committees and Health Authorities.
Good knowledge of Good Clinical Practices and all applicable EU regulations governing clinical research.
Authorisation to work in the job location without sponsorship.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.