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Allergan, Inc

Sr Manager, Clinical Programming

Allergan, Inc - Irvine, CA



Job Description

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
 
Position Description

The Senior Manager, Clinical Programming is responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems, external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J‐Review), and other programs (e.g. SQL, PL‐SQL, SAS).

Support strategic analysis of new systems and software to support clinical trials data collection, quality, and integrity. Support in the validation of electronic systems, software, and programs implemented internally according to current regulatory requirements. Also leads the implementation of programming standards and conventions. Supports development and
implementation of departmental Standard Operating Procedures (SOPs)and work practices. May contribute to department and other project budget planning.

All work activities conducted in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

Main Areas of Responsibilities

Clinical Programmer:

Responsible for the role which includes implementation of data capture systems and methods, member of the CRF Review Team, providing ongoing support to data capture, and generation of reports for use in ongoing data review and reconciliation.

Provides leadership and content expertise for programming activities from start‐up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.

Key contact for Clinical Data Management, Research& Development Quality Information Technology (RDQIT), Statistical Sciences and Programming(SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non‐Translational Sciences (NTS). 

External Vendor Management:

Responsible for the role which includes participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable Allergan processes and procedures. Involvement in assessment/re‐assessment of vendor capabilities, as necessary.

In addition, the incumbent is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO).

Process Owner/Subject Matter Expert:

Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Programming and other functions/departments as necessary.

Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Programming staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed.

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\t\t\t\t\t\t\tRequirements

The following listed requirements need to be met at a minimum level to be considered for the job:

Minimum 10 years of relevant professional experience.

Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).

Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.

Strong knowledge of global standards related to clinical programming activities (data standards, database design, coding and coding dictionaries, etc.). Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization.

Proven level of relevant work experience in Clinical Research, Computer Science, Project Management or related field.

 
Preferred Skills/Qualification

The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.

Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment.

Demonstrates a solution oriented approach to problem solving and a “can do” attitude. Ability to travel up to 15% of time.

 
 
Education
Bachelor’s Degree required.  

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13 days 23 hours ago

Allergan, Inc

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Sr Manager, Clinical Programming Allergan, Inc - Irvine, CA, United States

   

Location: Irvine, CA

Company Profile:
Allergan, Inc. operates as a multi-specialty health care company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological, and other specialty markets. It operates in two segments, Specialty Pharmaceuticals and Medical Devices. The Specialty Pharmaceuticals segment produces a range of pharmaceutical products, including ophthalmic products for dry eye, glaucoma, inflammation, infection, allergy, and retinal disease; Botox for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, eyelash growth, and other prescription and physician-dispensed skin care products; and urologics products. The Medical Devices segment offers a range of medical devices, such as breast implants for augmentation, revision, and reconstructive surgery, as well as tissue expanders; and facial aesthetics products. The company sells its products to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers, government purchasing agencies, and medical practitioners. It focuses on eye care professionals, neurologists, physiatrists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, urologists, urogynecologists, and general practitioners. The company has collaboration agreements with Molecular Partners AG; Spectrum Pharmaceuticals, Inc.; and Serenity Pharmaceuticals, LLC. Allergan, Inc. was founded in 1948 and is headquartered in Irvine, California.