Job Information
Sumitomo Pharma Senior Manager, Clinical Trials in Helena, Montana
Senior Manager, Clinical Trials
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://myovant-my.sharepoint.com/personal/gina_cromwell_myovant_com/Documents/Documents/072023%20Transition%20documents/JDs/Sumitomo-pharma.com) ]
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Clinical Trials . 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. The Senior Manager will perform assigned responsibilities to ensure timely completion of department goals and objectives with minimum supervision. The Senior Manager will disseminate clinical information to the clinical team members and Senior Director as appropriate.
Job Duties and Responsibilities
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.
Achieves and maintains compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Sumitomo Pharma are carried out with the best industry practices and the highest ethical standards.
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 Associate Director/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.
Key Core Competencies
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.
Education and Experience
Bachelor's degree from a four-year university or college.
6-10 years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
Specify the educational background required for the role.
Mention any preferred fields of study or certifications.
Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $116,100.00 to $152,400.00. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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 Sumitomo Pharma America (SMPA) and affiliates 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.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) 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)
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://protect-us.mimecast.com/s/ENgOCyPOPLtrAy4kHMAry5?domain=sumitomo-pharma.com/) ]
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas