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    Senior Manager Data Manager - Cambridge, Cambridgeshire, United Kingdom - Randstad Sourceright

    Randstad Sourceright
    Randstad Sourceright Cambridge, Cambridgeshire, United Kingdom

    1 week ago

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    Description

    Job Description Job title :
    Senior Data Manager


    Job Type:
    Permanent


    Location :
    Cambridge/ Remote (May have to travel to the Cambridge office on occasion)

    Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

    Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas.

    Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do.
    Job Purpose

    Lead all Clinical Data Management (CDM) lifecycle activities from protocol inception to database delivery for numerous global studies via oversight of multiple vendors and internal/external stakeholders.

    Provides oversight and prioritisation of work for vendors and is responsible for all deliverables for those studies. Identifies business and technical risks and proposes mitigation strategies. Communicates study timelines and deliverables to the study teams and follows up to ensure timely delivery. Accountable for delivery of quality data for project milestones, decision analysis and database locks. Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work. Coordinates user acceptance testing for clinical databases. Contributes to global and sub functional working groups and initiatives.

    Responsibilities

    Responsible for delivery of clinical global study databases and specific study related work using internal matrix management and external oversight of CROs and consultants.

    To deliver on internal projects related to research areas of interest aligned with R&D objectives.
    Provide expertise in the use of data management disciplines to design databases capable of delivering quality global studies. Vendor oversight for optimum database design and delivery to provide cost efficient solutions to the company.
    Input into centralised monitoring of global study databases focused on identification of data risks and mitigation strategies, inconsistent data, areas of missing data, data trends and unusual data distributions within and across sites and countries

    Key Interactions with internal functional representatives and study teams as well as external consultants and CROs undertaking outsourced activities.

    Externally represent Mundipharma at conferences and industry-wide initiatives.
    Process improvement and development within Data Science. Implementation of process changes in line with regulation and guidance changes
    Have key accountability for Vendor stakeholder management and working alongside vendors to hit key milestones
    Interrogation of Data is an essential part of the position
    Working as the sole Data Manager within the Team
    Key skills and experience

    ~ In depth knowledge of GCP and current legislation.
    ~ Working knowledge of Medidata Rave ( desirable but not essential) and IBM databases
    ~ Experience of delivering global clinical studies across different phases and therapeutic areas; experience of successfully managing different vendors. Experience within Pain (CNS), Oncology or anti-infectives or orphan drug clinical study data management would be advantageous.
    ~ Ability to work cross functionally, interpret information and critically assess performance of external consultants and CROs across all data management activities. Ability to confidently lead multi-functional delivery.
    ~ Ability to take responsibility and make informed decisions; ability to target oversight activities and build oversight plans to cover all elements of clinical study activity.
    ~ Experience of contract development, management and oversight including MSAs, work orders, scope documentation development and change order negotiation.
    ~ Ability to prioritise, work flexibly and think strategically.
    ~ BSc or equivalent in science discipline - BSc or equivalent in science discipline and post degree qualification in clinical research such as MSc or diploma
    ~5 years' experience within a Pharma company or CRO delivering multiple clinical studies across different therapy areas and phases from I-IV. Knowledge of working in different environments or with different CROs/companies.
    ~ Senior Leadership experience working with Key Stakeholders & Vendors

    We appreciate your interest in joining our organisation.

    If the current opportunity doesn't align with your career aspirations, we encourage you to join one of our talent pools.

    By doing so, our recruiters will have the opportunity to connect with you when a suitable role becomes available based on your CV.

    We value your skills and expertise, and we look forward to potentially collaborating with you in the future.
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