Clinic Study Manager

Teva Pharmaceuticals • Miramar, FL

21h

About The Position

We Are TevaWe’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.The opportunityJob Summary:The Clinical Study Manager oversees and maintains the successful execution of a clinical study from project start-up and protocol drafting to completion of the study, CSR drafting/review, and close-out with IRB. During study conduct, the Clinical Study Manager directs and coordinates the clinical operations study team to ensure that all study activities are conducted in accordance with Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable, while emphasizing strict compliance with the study protocol at all times.

Requirements

• Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
• A bachelors degree or a R.N or L.P.N
• Minimum of two years of experience working in a clinical research environment is required.
• Possesses working knowledge of medical terminology
• Able to obtain vital signs and perform ECGs
• Able to use advanced scientific interpretation
• Capable of performing basic accounting tasks
• Able to provide excellent customer service while maintaining a professional attitude with both external clients and site staff
• Proficient in MS Office (e.g. Word, Excel, Power Point, Outlook)
• Able to work independently and handle multiple competing priorities
• Possesses excellent organizational and time-management skills and a strong attention to detail
• Able to speak, read, and write English fluently; Bilingual (English/Spanish) beneficial
• Routine keyboarding
• Variable hours including nights and weekends

Nice To Haves

• CCRC, CRP or CRA certification is preferred.

Responsibilities

• Serves as the primary internal point of contact for all issues related to trial conduct
• Collaborates with the Principal Investigator (PI) to provide leadership and project guidance for the study conduct team
• Coordinates and communicates study status throughout the study and is responsible for planning and supervising study conduct from study award through delivery of the final Clinical Study Report (CSR) followed by IRB Study close-out
• Liaises with the study Sponsor and/or their representatives, including third-party vendors as needed, ensuring that client timelines and deliverables are met throughout all stages of the study conduct
• Personally reviews draft protocols and coordinates their review by the PI and pertinent site staff and compiles those comments and suggestion from all departments for provision to the study Sponsor and/or protocol writers
• Reviews all study documentation including but not limited to, Informed Consent, CRF's and clinic training to ensure compliance with Final protocol
• Ensures that significant study related issues (i.e. Serious Adverse Events, issues pertaining to the protocol, SOPs, or regulatory deviations and/or violations) are escalated to the PI, IRB and the study Sponsor, as appropriate, in a timely manner
• Participates in the operational planning and implementation of study design and preparedness, oversees its appropriate organization, scheduling, and execution   Provides the PI, study Sponsor, as well as members of clinic management and operational teams, continuous updates regarding timelines and deliverables, regulatory submissions, subject safety, study milestones, recruitment and screening updates, conduct activities, data entry/coordination, and study closeout
• Oversees, coordinates and participates in the execution of study trials including activities related to protocol procedures, regulatory requirements, administrative actions, and study close-outs, as needed
• Coordinates with other clinic departments that contribute to development of data tables and delivery of Case Report Forms for inclusion into CSR
• Personally compiles necessary study information and prepares data tables for inclusion into CSR
• Works with clinic staff scheduling department to ensure that the appropriate resources are available for study project success
• Provides operational and participatory support

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level