{"id":3310,"date":"2014-11-07T00:00:00","date_gmt":"2014-11-07T00:00:00","guid":{"rendered":"https:\/\/medschool.prd.vanderbilt.edu\/career-development\/2014\/11\/07\/job-posting-clinical-operations-manager-foundation-for-the-national-institutes-of-health-bethesda-md\/"},"modified":"2018-12-10T15:37:58","modified_gmt":"2018-12-10T15:37:58","slug":"job-posting-clinical-operations-manager-foundation-for-the-national-institutes-of-health-bethesda-md","status":"publish","type":"post","link":"https:\/\/medschool.vanderbilt.edu\/career-development\/2014\/11\/07\/job-posting-clinical-operations-manager-foundation-for-the-national-institutes-of-health-bethesda-md\/","title":{"rendered":"Job Posting: Clinical Operations Manager, Foundation for the National Institutes of Health, Bethesda, MD"},"content":{"rendered":"<p>The Foundation for the National Institutes of Health (FNIH) is seeking a full-time Clinical Operations Manager to help manage a large, multidrug Phase II-III oncology trial under a public-private partnership managed by FNIH that includes participation by the National Cancer Institute (NCI) and its Cooperative trials management group, the Southwest Oncology Group (SWOG); the Food and Drug Administration (FDA); the biopharmaceutical industry, and non-profit patient advocacy groups.<\/p>\n<p>The Clinical Operations Manager will report to the FNIH Cancer Program Manager, will directly support the trial&#8217;s Principal Investigators and will work collaboratively with project management staff at SWOG to ensure both the strategic and the operational success of the trial. This is a high level management position that also involves liaising with the government and private sector partners in the trial. The position will be based in FNIH&#8217;s Bethesda, Maryland offices, but will require extensive U.S. travel (e.g., San Antonio, Houston, New Haven) for meetings related to this project.<\/p>\n<p><strong>ESSENTIAL FUNCTIONS<\/strong><\/p>\n<ul>\n<li>Works closely with the trial&#8217;s Principal Investigators in maintaining the appropriate scientific and strategic direction of the trial, including drug and biomarker selection, trial amendments, and managing relationships among investigators, including running regional investigator meetings.<\/li>\n<li>Provides project management support for NCI and FDA filings, and related issues, working among the stakeholders.<\/li>\n<li>Works collaboratively with the SWOG Project Manager to ensure smooth and successful execution of the trial, including accrual, data management, safety reporting, sample and assay processes, human subjects issues, etc.<\/li>\n<li>Interacts directly with the sites where requested, including telephone contact with site Principal Investigators and Clinical Research Associates to assess and troubleshoot site activation and accrual issues.<\/li>\n<li>Tracks project timelines and the overall trial budget, particularly with respect to collection and distribution of private sector funds contributed to the trial through the FNIH.<\/li>\n<li>Facilitates meetings and interacts with the clinical project team to identify issues that might delay the project, and makes recommendations about how most efficiently to achieve project completion.\u00a0<\/li>\n<li>Supports the Trial Oversight Committee and public-private partners to provide communication on trial progress and issues and insure satisfaction of all stakeholders in the conduct of the trial.<\/li>\n<li>Provides organizational support for webinars, educational meetings and conferences related to this or future protocols.<\/li>\n<\/ul>\n<p><strong>MINIMUM QUALIFICATIONS<\/strong><\/p>\n<p>Work requires a Master&#8217;s Degree or higher (PhD preferred) in biomedical science or a related field and at least five years&#8217; experience in clinical trial project management; or any equivalent combination of education and experience that provides the following knowledge, abilities and skills:<\/p>\n<ul>\n<li>Knowledge of clinical trials logistics and policies, with 3+ years of experience managing clinical trials in a pharmaceutical company (or CRO on behalf of a company), or NCI cooperative group.<\/li>\n<li>Experience with and knowledge of oncology clinical trials a plus<\/li>\n<li>Experience in working collaboratively with professionals from diverse sectors (government, academia, and\/or private industry);<\/li>\n<li>Superior interpersonal and communications skills<\/li>\n<li>Ability to multitask, including working across complex projects;<\/li>\n<li>Ability to learn quickly, make difficult decisions independently in order to meet tight deadlines;<\/li>\n<li>Attention to detail;<\/li>\n<li>Ability to conduct succinct presentations;<\/li>\n<li>Strong analytical and organizational skills;<\/li>\n<li>Ability to demonstrate diplomacy as well as initiative when working with others.<\/li>\n<\/ul>\n<p><strong>LICENSES, CERTIFICATION AND OTHER REQUIREMENTS<\/strong><\/p>\n<p>None<\/p>\n<p><strong>Benefits<\/strong><br \/>Fully paid medical and life insurance, 11 paid holidays, fully paid short-term and long-term disability insurance, and a generous 403(b) retirement plan. Salary is competitive and commensurate with experience.<\/p>\n<p><em>The FNIH is an equal opportunity employer and does not condone or tolerate discrimination based on race, color, religion, sex, national origin, age, physical or mental disability, or sexual orientation.<\/em><\/p>\n<p>The Foundation employs only United States citizens and those non-U.S. citizens authorized to work in the United States in compliance with the Immigration Reform and Control Act of 1986.<\/p>\n<p class=\"h3\"><strong>How to Apply<\/strong><\/p>\n<p>Email your cover letter, resume, three references and your salary requirements to Subject: Scientific Program Manager, Cancer at\u00a0<strong><a href=\"mailto:resumes@fnih.org\">resumes@fnih.org<\/a><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Foundation for the National Institutes of Health (FNIH) is seeking a full-time Clinical Operations Manager to help manage a large, multidrug Phase II-III oncology trial under a public-private partnership managed by FNIH that includes participation by the National Cancer Institute (NCI) and its Cooperative trials management group, the Southwest Oncology Group (SWOG); the Food&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[100],"tags":[25,19,7,11],"class_list":["post-3310","post","type-post","status-publish","format-standard","hentry","category-job-opportunities","tag-career-options-clinical-research","tag-career-options-government-administration","tag-job-opportunities","tag-job-posting-non-faculty"],"acf":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/posts\/3310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/comments?post=3310"}],"version-history":[{"count":1,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/posts\/3310\/revisions"}],"predecessor-version":[{"id":7443,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/posts\/3310\/revisions\/7443"}],"wp:attachment":[{"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/media?parent=3310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/categories?post=3310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/career-development\/wp-json\/wp\/v2\/tags?post=3310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}