Mallinckrodt Pharmaceuticals Senior Manager, Clinical Operations in Hampton, New Jersey
Senior Manager, Clinical Operations
JR000011230 Senior Manager, Clinical Operations (Open)
US Specialty Brand Headquarters - USA501
The Senior Manager, Clinical Operations manages and performs Global Clinical Trial Registration & Results Disclosure activities including registration of protocols and results postings on appropriate clinical trial registries and development and implementation of clinical trial transparency activities in accordance with relevant laws, regulations, and SOPs. The Senior Manager is also responsible for identifying opportunities to improve systems and processes related to clinical trial conduct and autonomously lead process improvement initiatives for Global Development Operations. When requested, the Senior Manager, Clinical Operations will be responsible for leading global clinical trial operational activities and managing their execution to ensure completion according to project timelines and budget.
Consults with relevant team functions within Clinical Development and Clinical Development Operations and other stakeholders such as Medical, IP/Legal, Biostatistics, Regulatory Affairs, and Medical Writing to review protocol information to obtain accurate, appropriate information for public disclosure.
Assists trial teams with the collection of required information for postings, answer their questions regarding posting requirements and public results disclosure and train the S&T organization on the Mallinckrodt disclosure and transparency process
Provides trial teams with requirements from applicable disclosure laws and guidance and internal processes and interprets registry/template requirements as appropriate for the study
Monitors, communicates and proactively plans in response to changes in global Clinical Trial Disclosure and Transparency Regulations
Due to the rapidly evolving nature of the disclosure landscape, must be able to leverage self-study, ongoing learning, etc. to remain abreast of developments in trial disclosure
Enters the initial protocol information and revised protocol information on clinicaltrials.gov and other websites as required by international law/guidance
Updates existing registries with changes in ongoing clinical trial status including recruitment status, protocol amendments, site updates and actual dates
Consult with relevant functions to assimilate the required results data fields for posting
Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies
Manages the Clinical Operations hotline and central mailbox
Communicates registrations and results dates and links to relevant stakeholders
Develops processes and procedures for clinical trial conduct and provides guidance to internal and/or external staff in the execution of day-to-day activities
Participate in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)
Effectively communicates internal compliance metrics within Mallinckrodt
Leads global process development and procedural document revisions
Proactively identifies opportunities to improve systems and processes and autonomously lead process improvement initiatives for Global Development Operations
Work with vendors and CROs, as needed
Department specific/Non-essential responsibilities:
Develops and coordinates global clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget
Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (eg, Clinical Science, Regulatory Affairs, Data Management)
Develops in conjunction with CRO partners and functional area leads, clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
Other duties as assigned with or without accommodation.
Experience / Skills:
BA/BS degree or higher, preferably in the life sciences.
Must have at least 3 years of experience disclosing and reporting on clinical trial data.
Must have at least 3 years of experience managing clinical trials
Must have at least 8 years of overall experience with in the Pharmaceutical Industry
Exceptional attention to details and ability to analyze and assess data
Understands the legal/regulatory requirements and guidelines regarding clinical trial conduct including disclosure
Understands the clinical drug development process, including clinical trial design, operations and results analysis
Strong critical thinking, analysis, and problem-solving skills
Ability to review clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
Working understanding of global regulatory requirements and other policies (eg, GCP, ICH, ICMJE) related to clinical trial conduct
Able to accomplish work independently and as part of a team
Ability to manage deadlines and deliver on time with high quality output
Team player as demonstrated by good communication/collaboration skills
Positive attitude and ability to establish and maintain positive working relationships
Excellent written and verbal skills
Experience with the Microsoft Office suite (i.e., Word, Visio, Excel, PowerPoint, etc.) and Adobe.
Intermediate understanding of the requirements of initial and results posting requirements for clinicaltrials.gov and EudraCT
Intermediate understanding of the principles and requirements of GCP, ICH PhARMA, EFPIA, and ICMJE
Ability to identify area of mis-alignment in what stakeholders expect of the department and identify areas to reset expectations
Consistently demonstrates an ability to support innovations in order to mitigate identified risks
Advanced understanding of the development of risk management and/or remediation plans
Actively develops and implements changes to improve quality within the functional area.
Possesses enhanced knowledge of clinical operations
Ability to work in a virtual setting/across time-zones and make effective use of communication tools (WebEx and video conferencing)
Ability to listen effectively and the capability to effectively communicate ideas and data both verbally and in writing in a persuasive
and appropriate manner to a broad array of stakeholders
Ability to manage competing priorities demonstrating adaptability in meeting prioritized deadlines
Ability to lead others by influencing (i.e., without direct line management)
Strong strategic thinking skills and ability to quickly analyze and structure problems
Self-driven individual able to function with minimal supervision
Travel as needed, but not expected to exceed 10%
Reports to: Senior Director, Global Development Operations Process and Systems or Director, Clinical Trial Disclosure and Transparency
Direct Reports for the Senior Manager, Clinical Trial Disclosure and Transparency: None
This position is located in Hampton, NJ but would consider someone on a remote basis with the ability to report to the office once a month based project needs.
Standard office environment
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.