Sunovion Senior Manager, Clinical Trials in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Senior Manager, Clinical Trials to join our Research and Development (R&D) Clinical Operations team.
This position is responsible for the clinical planning process and for all aspects of the management of clinical operations for one or more clinical trials including resource management. This position is responsible for clinical trial conduct including project planning, budget management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. Performs assigned responsibilities to ensure timely completion of department goals and objectives with minimum supervision. Disseminates clinical information to the clinical team members and Director as appropriate.
Manages/oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
Assist with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones.
Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines.
Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports and reviews and approves monitoring reports as appropriate. Reviews CRO site monitoring calendars, tracks site visits, tracks monitoring report issuance and receipt, conducts initial reviews of reports, to assure that full internal reviews are conducted on a timely basis.
Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of annual reports, IB updates.
Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.
Participates in special projects as appropriate.
Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues.
Keeps management informed by escalating issues requiring intervention to the study and project teams under the supervision of the Director.
Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues.
Minimum Education, Experience, Knowledge and Skills:
Bachelor's degree from a four-year university or college; and six to ten years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP.
Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
Ability to manage complex and global clinical trials.
Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.
Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English.
Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.
Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.
Must have experience interfacing and managing multiple vendors/ contractors.
Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.
Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel.
Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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