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Clinical Operations Manager US - Remote

Company: Idorsia Pharmaceuticals US Inc.
Location: Cherry Hill
Posted on: November 23, 2022

Job Description:



The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia intoa leading biopharmaceutical company, with a strong scientific core.



Headquarterednear Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania. Idorsia is committed to meet the changing needs of healthcare professionals, patients, and their families. The core of what we do is to bring creative solutions to the market based on our science and data.


The Clinical Operations Manager drives the development of the operational trial related documents and procedures, as well as setting-up the External Service Providers (ESP's) and supervising the deliverables of all ESP related activities, from specifications to close-out. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESP's.



Key Responsibilities:




  • Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines.
  • Manage the selection of ESPs in collaboration with other functions.
  • Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
  • Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to the Clinical Trial team (CTT).
  • Lead the development of trial-related operational documents.
  • Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators).
  • Resolve operational issues in a proactive and timely fashion.
  • Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions
  • Approve invoices (e.g., site payments) and ensure related payments are made in a timely manner.
  • Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review.
  • Actively participate in investigator meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
  • Mentor team members as needed.
  • Assume responsibility for other project or trial-related duties as assigned.




    Qualifications:




    • Bachelor of Science degree in life sciences or healthcare (internationally validated equivalent also considered) required.
    • 4 years of experience managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report is required.
    • Experience in working in global cross-functional (matrix) and multicultural teams.
    • Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
    • Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
    • Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
    • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).



      • Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.
      • Position may require international travel.




        Behavioral skills:




        • Strong interpersonal, communication (written and verbal), collaboration and organizational skills.
        • Self-motivated and able to work independently and proactively.
        • Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment.
        • Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills.
        • Demonstrate ability to work in multi-functional and cross-functional teams: effective teamwork and collaborative relationships.
        • Able to share expertise and experience with team members and across teams.



          At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.



          Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.



          Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

Keywords: Idorsia Pharmaceuticals US Inc., Cherry Hill , Clinical Operations Manager US - Remote, Executive , Cherry Hill, New Jersey

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