Clinic Study Manager

We Are Teva

We’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 opportunity

Job 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.

Essential Functions

• 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

Your experience and qualifications

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education:

• A bachelors degree or a R.N or L.P.N

Experience:

• Minimum of two years of experience working in a clinical research environment is required.

Certification/Licensure:

• CCRC, CRP or CRA certification is preferred.

Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

• 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

Physical Requirements and Working Conditions:

• Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.

Physical Demands:

• Routine keyboarding
• Variable hours including nights and weekends

Work Environment:

• Office environment and clinical environment
• Non-supervisory, non-managerial

How We’ll Take Care of You 

We offer a competitive benefits package, including:
•    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.

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.    

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.   

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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.