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Global Clinical Protocol - Late Phase Sponsored Research with Oncology

Company Name:
Alpha Consulting Corp.
GLOBAL CLINICAL PROTOCOL - LATE PHASE SPONSORED RESEARCH WITH ONCOLOGY

REQUIREMENT #14-00927
RECRUITER: CINDI PISNOY
JOB LOCATION: PLAINSBORO, NJ
SEPTEMBER 2, 2014

Expected Areas of Competence:

General
Manages successful execution and completion of assigned global clinical Phase IIIb/IV publication/medical informing trials within CSR&O Late Phase Sponsored Research unit, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
Responsible for clinical operational oversight and tactical execution of assigned trials in order to successful deliver on expectations of quality, timelines and budget, including protocol development, patient informed consent review, collection of regulatory documentation, contract and budget negotiations, and drug supply management.
Builds and sustains extensive global networks across multiple functions at study team level

Financial Accountability
Manages study operational budgets and monitors overall agreed budget against trial progress. Works closely with internal and external stakeholders to ensure team awareness of suppliers' budget and deliverables to minimize ambiguity and unwarranted change orders, so both can be managed appropriately.

Relationships
Manages global business relationships with AROs/SMOs, investigational sites and networks, key opinion leaders, suppliers, etc. involved in assigned studies to ensure appropriate stakeholder engagement and support.
Manages relationships and maintains open communication with various stakeholders across Medical Operations, WWMT, and Hubs to ensure agreed upon support and engagement is available to successfully meet projected trial timelines, trial execution and completion, and projected CSR and publication commitments.
Manages suppliers' performance to ensure adherence to agreed deliverables within timelines and budget at overall trial level. Specifically, tracks and evaluates trial milestones and monitors overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Whenever possible, resolves issues that have been escalated and/or take issues to assigned AD and/or appropriate management.

Trial Management
Manages cross-functional, integrated trial plan to ensure that timing of all major trial milestones and associated budget meet needs of overall development plan agreed across relevant functional areas and WWMT. Coordinates updates, including presentations and communications on assigned trials, to AD and/or management.
Manages supplier relationship and provides timely input to ensure that trials are executed according to agreed project plan. Works with AD to ensure trial risk assessment is complete, and that mitigation and contingency measures are prepared and implemented. Actively assesses potential risks to trial and implements mitigation plans, as needed.
Serves as the global point of contact for operational and process related issues and inquiries for assigned trials.
Takes specific responsibility to manage quality of trial initiation, execution, recruitment efforts, and monitoring activities, plus activities related to successful data base lock (DBL). Liaise with suppliers and internal stakeholders to ensure timely DBL is achieved, and successful delivery of CSR and publications is provided


SOPs/Processes & Procedures
Manages ongoing training on required Company SOPs/GCP, systems and processes, current relevant medical and scientific knowledge required to fulfill role and responsibilities.
Manages appropriate implementation, conduct, tracking and reporting of assigned trials including quality review of trial information within Clinical Trial Management System (CTMS) and other systems used to support and manage CSR&O assigned responsibilities
Identifies and assists with opportunities for process development, improvement and implementation of policies, procedures and processes related to Late Phase Sponsored Research activities
Assists with drafting/revising related department SOPs, procedures, policies that may impact Late Phase Sponsored Research activities.


Qualifications

Experiences Desired
Bachelor's degree required in science related field. Advanced degree preferred.
5-8 years of global clinical trial experience in pharmaceutical/biotech industry and/or related healthcare industry with at least 3 years of executing global Phase IIIb/IV trials
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with Phase IIIb/IV programs
Oncology clinical trial management experience strongly preferred
Ability to flex, develop and maintain expertise in assigned therapeutic/research areas to be clinical and operational resource to internal and external BMS stakeholders
3-5 years of CRO and supplier management experience including governance and due diligence, supplier evaluation and performance process, contract content and budget management, interfacing with supplier counterparts and management to manage resolution of issues and conflicts, etc.
Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP and the ability to deliver trials on time and within budget.
Demonstrated knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
Demonstrated exceptional communication and organizational/time management skills, and ability to collaborate, align and manage diverse, global cross-functional matrix teams.
Demonstrated flexibility, open-mindedness, and adaptability to a rapidly changing regulatory environment.

Knowledge Desired
Knowledge of global clinical trial process, with specific focus on global Phase IIIb/IV trials.
Understanding of principles, and implementation and maintenance of GCP and regulations.
Knowledge of global trial planning and management principles, and business processes, including contracting and budgeting.
Knowledge of current medical/scientific information relevant to brands, competitors, and disease areas supporting.
Knowledge of how best to impact upon and influence individuals and groups utilizing effective leadership, communication, negotiating skills, etc.

Developmental Value
Develop broader understanding of Late Phase Sponsored Research group within CSR&O and Medical Operations
Increase exposure to larger sphere of CSR&O and BMS colleagues and management through interactions with individuals across multiple functions and at different levels on a global basis
Enhance leadership and influencing skills by managing situations and individuals in a matrixed team environment
Manage significant budgetary responsibilities
Enhance understanding of how decisions and actions impact overall CSR&O group
Enhance strategic thinking, planning, communication and implementation skills
Enhance understanding of all aspects of late phase product activities, including commercialization, marketing, regulatory, legal, and clinical development

Additional Skills
Bachelor's degree required in science related field. Advanced degree preferred.
5-8 years of global clinical trial experience in pharmaceutical/biotech industry and/or related healthcare industry with at least 3 years of executing global Phase IIIb/IV trials
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with Phase IIIb/IV programs
Oncology clinical trial management experience strongly preferred
Ability to flex, develop and maintain expertise in assigned therapeutic/research areas to be clinical and operational resource to internal and external BMS stakeholders
3-5 years of CRO and supplier management experience including governance and due diligence, supplier evaluation and performance process, contract content and budget management, interfacing with supplier counterparts and management to manage resolution of issues and conflicts, etc.
Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP and the ability to deliver trials on time and within budget.
Demonstrated knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
Demonstrated exceptional communication and organizational/time management skills, and ability to collaborate, align and manage diverse, global cross-functional matrix teams.
Demonstrated flexibility, open-mindedness, and adaptability to a rapidly changing regulatory environment.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi:

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