Global Trials Manager

4 weeks ago

hyderabad, India Michael Page Full time
Opportunity to work with a leading healthcare MNC Best in-class industry experience and benefits

About Our Client

A global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients worldwide.

Job Description

* Directs and delegates to assigned Global Trial Management staff as applicable.
* Drives study execution utilizing available performance metrics and quality indicators ( CTMS, eTMF reports, RBM reports), and study milestones and drivers.
* Develops, manages, and maintains study deliverables ( timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.
* Proactively identifies potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs.
* Maintains and updates data as appropriate in project management tools including CTMS.
* Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and recruitment status and raises potential issues/mitigation.
* Requires minimal oversight to lead/manage projects.
* Identifies, participates and/or leads initiatives with cross-functional/global teams.
* Leads Study Team meetings, defines the agenda, captures meeting minutes, and facilitates cross-functional discussions.
* Creates, maintains, and implements project management tools at the study level ( actions, decisions, issues log and risk management plan).
* Provides input to data, protocol deviation review, and patient tracker.
* Provides strategic input into Study Team - , on study documents. Collaborates with CSO on global investigational product (IP) supply forecasting/management.
* Participates in the subject recruitment/retention strategy and related initiatives ( recruitment material).
* Participates in clinical service provider (vendor) selection, specification development, and management / oversight.
* Oversees TMF set-up, ongoing quality review, and operational oversight memo and requests final reconciliation
* Oversees eCOA activities throughout the lifecycle of the study.
* Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
* Oversee study specific CSR appendices.
* Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.
* Promptly shares information with key internal/external stakeholders at regular meetings.
* Proactively identifies and anticipates issues and risks and oversees the creation of mitigation plans and implements resolutions.
* Oversees service providers with minimal supervision.
* Leads Audit Response Team and CAPA and participates in inspections.
* Supports the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget. Study Planning and Conduct - Outsourced Studies
* Reviews/approves functional plans ( SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements). Provides information to the CRO and reviews CRO deliverables.
* Sets up and maintains Protocol Level training curriculum in SuccessFactors.
* Reviews Protocol Level training for IM and SIV.
* Owns overall and end-to-end study project management responsibilities.
* Provides oversight and reviews all outsourced activities (protocol to CSR) in Clinical Pharmacology (NHV) studies. Relationship Management
* Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
* Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.
* Ensures appropriate methods are used when communicating with key stakeholders and cross functional partners.

The Successful Applicant

Degree Requirements
* BA/BS or equivalent degree in relevant discipline Experience Requirements
* Minimum 4 years of demonstrated project management experience of which at least 2 should have been in the pharmaceutical or healthcare industry.
* Experience in leading global clinical trials and multi-functional teams.
* Demonstrated project management and organizational skills with strong presentation and communication abilities.
* Experience with electronic quality, compliance and CTMS systems. Experience in managing CROs is a plus.
* Risk management experience Competency Requirements Technical Competencies
* Clinical trial project management skills.
* Financial budgeting and forecasting skills are a plus.
* In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
* Proven success in using oral/written communication skills to influence, inform, or guide others.
* Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint
* Proficiency in study tools including electronic system skills - CTMS/eTMF.
* Demonstrated project management and organizational skills with strong presentation and communication abilities.
* Ability to manage multiple deliverables and nimbly respond to changing business demands.
Management Competencies
* Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people.
* Reacts with a sense of urgency and responds appropriately.
* Critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
* Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
* Adaptable and flexible-willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism.
* Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside (as appropriate).
* Has the ability to review, interpret, and analyze information to support discussions and make decisions.
* Ability to effectively lead a cross-functional team in a matrix environment.
* Time management skills - ability to effectively multi-task and set priorities with minimal guidance.
* Comes with ideas or perspectives when seeking guidance from Operations Portfolio Leads and/or other team members.
* Fosters a continuous learning mindset.

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