Associate Clinical Study Manager
Associate Clinical Study Manager
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$ 77200 - 160800
1 Vacancy
Job Description
Stryker is hiring an Associate Clinical Study Manager to support our Trauma & Extremities division! In this role you will assist with the planning and oversight of one or more clinical studies. As an integral part of the Clinical Research team youll support key project activities helping ensure patient safety data integrity and compliance with all applicable SOPs and regulatory requirements. You will play a critical role in keeping studies on time and within budget.
This is a virtual role seeking candidates in the Eastern or Central US time zones.
What youll do:
Serve as the direct point of contact for investigator sites and build strong working relationships with clinical site staff key opinion leaders and colleagues.
Support new and ongoing clinical research activities ensure efficient and timely processing of confidentiality and clinical agreements.
Supports the clinical project plan including study budget. Writes and develops the protocol informed consent and other study specific documents.
Manages site nomination qualification and selection process. Conduct onsite monitoring and study closeout visits write reports and site correspondence comonitors (trains and evaluates) other CRAs and CSCs.
Conduct clinical monitoring and/or auditing of field sites to supervise and coordinate clinical studies.
Designs develops and tests the CRFs and databases in collaboration with the clinical study manager and study data manager.
Manages site regulatory submission and approval process. Responsible for country regulatory submission and approval internally or with vendors. Collects files and tracks site regulatory documents.
Supports management of clinical data and regulatory reports and timely management of study publications.
Ensure studies are conducted in compliance with GCP SOPs and all applicable ethical and regulatory standards.
Perform periodic audits of study files for completeness and support SOP development and training as procedures evolve.
Process and track site payments and patient reimbursements
Participate in continuous improvement activities and process reengineering projects in support of continual improvement initiatives
What you need:
Required:
Bachelors degree required. Preference for degrees in health science biological sciences engineering or related medical/scientific field.
2 years experience directly supporting clinical research or similar experience in a medical/scientific area.
Preferred:
Expertise with GCPs and regulatory and compliance guidelines for clinical trials.
Experience in site management monitoring and clinical documentation systems.
This role may require up to 50 travel though this represents the upper end of the travel expectation.
$77200 $160800 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 50Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Manager
Employment Type
Full-Time
