Shire Study Start-up Lead in Cambridge, Massachusetts
This position is a member of the Safety Operations team within Global Drug Safety (GDS). This position serves as Head of the Study Start-up Team. The Head of Study Start-up will serve as a facilitator and communicator between Clinical Operations and Safety Operations in the development and implementation of processes in the partnership model.
% of Time Job Function and Description
25% Be the point of contact and primary decision maker on the development and improvement of processes involving Safety Operations in the Shire Partnership Model. Work With Drug Safety Surveillance to represent GDS in this model
25% Manage the Study Start-up team by ensuring quality and consistency in the team’s production of study start up materials. This including providing training of new processes and requirements and being the primary escalation point for issues arising from individual studies.
20% Perform clinical study start up activities including support of creation and update of Safety Management Plans, Reconciliation Plans, Electronic Case Report Form review, SAE form creation, request Argus study configuration and management/review of other study related documents
10% Collaborate and interface with relevant counterparts in the regional and country drug safety functions to facilitate the global exchange of safety information.
10%Interface with other groups (e.g. Quality, Regulatory Affairs, Marketing, IT, etc.)
5% Mentor and train new GDS staff
5% Participate in audits and inspections as needed (Subject Matter Expert, scribe, runner)
Education and Experience Requirements
Required Degree: Associate’s or Bachelor’s degree for Nursing
Bachelor’s degree or Pharm D for Pharmacy
Preferred Degree: Nursing: Bachelor’s degree
Pharmacy: Pharm D
Minimum of 5 years’ experience in pharmaceutical industry
3-5 years of clinical study experience
Expertise with global Pharmacovigilance regulations, processes, and requirements
Key Skills, Abilities, and Competencies
Strong clinical and medical knowledge base
Excellent analytical and problem solving skills
Excellent oral and written communications skills
Collaborative interpersonal skills to foster team environment
Ability to work independently under strict timelines and changing priorities
Self-motivated in learning new tasks and responsibilities
In depth knowledge of ICH and EMA Guidelines on Good Pharmacovigilance Practices (GVP)
Ability to multitask and prioritize changing workload for self and others on a daily basis
Ability to establish priorities for self and others & proceed with objectives
Strong knowledge of drug safety database and conduct of clinical studies
Knowledge of multiple therapeutic areas
Ability to prioritize workload
Adaptable to change
Complexity and Problem Solving
Identify key areas that can be standardized and streamlined between studies Understand regulatory reporting requirements and how to implement them into a study process
Identify when the Global Safety Lead needs to be involved to make medical judgment decisions. Be able to facilitate between various teams between the CRO, internal GDS, the vendor and other Shire departments. Identify process improvement solutions between GDS and the clinical teams
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.