Clinical Trial Manager - Newark, CA | Biospace
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Clinical Trial Manager

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
4/24/2017
Position Type:
Full time
Job Code:
871XX
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Clinical Trial Manager
Job ID 871XX
Date Added 1/18/2017
Department Clinical Operations

Description

JOB SUMMARY
The Clinical Trial Manager will be responsible for assisting in the execution of clinical protocols within a clinical development program. The Clinical Trial Manager will work closely with cross-functional representatives, including Clinical Affairs, Biostatistics, Data Management, Regulatory/QA, Drug Safety, Pharmacology, CMC, etc. to ensure successful completion of all clinical activities/project deliverables within the established budget and timelines. The Clinical Trial Manager will also assist in the oversight of the CRO and other third party vendors as necessary.

Clinical Operations will directly manage sites or manage CROs who may manage study sites. Clinical Operations is responsible for such tasks as selecting study sites and investigators, managing investigator meetings, managing study conduct and progress, clinical monitoring of sites or managing CROs who are engaged to monitor study conduct. Responsibilities also include but are not limited to the preparation of IRB documents and the maintenance and creation of Clinical Operations SOPs. Support will be provided to the writing of study protocols, statistical analysis plans (SAPs) and clinical study reports.

ESSENTIAL JOB FUNCTIONS
•Assist in the oversight of CROs and third party vendors, including co-monitoring, to ensure compliance with study protocol.
•Responsible for project start-up activities including but not limited to: site feasibility, site selection/recommendation, and regulatory preparation in conjunction with relevant departments.
•Monitor performance of investigational sites; prepare or review visit reports.
•Ensure studies are carried out according to the study protocol, applicable SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
•Track and report on study progress and key study metrics.
•Reviews and approves the EDC system, study manuals, study plans and other study related materials.
•Perform clinical data review of data listings and summary tables. Generate queries as necessary.
•Oversee discrepancy management, ensure queries are appropriate and responses are timely.
•Manage study drug accountability, shipments, reconciliation and return process.
•Provides site, CRO and vendor training on new or amended protocols and other study materials as appropriate
•Reviews invoices from sites, CROs and third party vendors to ensure work has been completed satisfactorily prior to payment.
•Provides support in the development of clinical protocols, SAPs, consent forms, and other program/study related documents.
•Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners.
•Works with the Head of Clinical Operations, legal, and finance (as well as other cross-functional team members as necessary) in the selection of CROs and other third party vendors.
•Member of cross-functional clinical trial teams (internal and external) representing Clinical Operations.

ADDITIONAL RESPONSIBILITIES/DUTIES
•Monitoring of clinical investigational sites (including PSSVs, SIVs, IMV, COV, co-monitoring and audit related activities).
•Ability to write/edit clinical study documents in a coherent and complete manner.
•Other duties as assigned.

Requirements

EDUCATION AND EXPERIENCE
•Science background BS or healthcare degree
•5-7+ years clinical experience in a pharmaceutical/biotech or CRO setting
•5+ years as a site monitor
•Experience managing all phases of clinical trials
•Experience working in a fast paced environment with limited resources
•Experience managing CROs and vendors

SKILLS AND ABILITIES
•Ability to effectively work within cross-functional teams
•Excellent interpersonal, organizational, and multi-tasking skills
•Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
•Experience with Electronic Data Capture systems
•Ability to use MS Programs (e.g. Word, Excel, Outlook etc.)

DEPOMED COMPETENCIES INCLUDE
•Integrity and respect: Honest, trustworthy and accountable. Ensures all activities performed by the Depomed study team, vendors and investigative sites are done ethically and according to Depomed procedures and regulatory guidance. Shows respect for all team members (internal and external).
•Decisions & Judgment: Works closely with the appropriate team members and upper management to ensure adherence to the study protocol. Provides clear and prompt communication to upper management in order to minimize any negative impact to study integrity, timelines and/or budget.
•Accountability: Takes ownership for work performed. Accepts responsibility for actions and decisions made during the operational conduct of the clinical study.
•Agility: Able to quickly adapt to study changes. Communicates and implements changes in a positive manner.
•Teamwork & Collaboration: Open, honest and positive communication with the cross-functional team members, investigative sites and external vendors.

PHYSICAL/MENTAL DEMANDS
•Sitting – 80%
•Standing/ walking – 20%
•Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day
•Visual Requirements: Able to see and read PC screens and read fine print
•Ability to hear what clients are saying in a normal conversation
•Lifting: Ability to carry items weighing less than 10 pounds
•Travel domestic/international 10-30%
•When not traveling maintain in-office, regular work hours to facilitate interactions with other employees

About Us

Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.


Depomed is an AA/EEO/Veterans/Disabled employer.
Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.


Depomed is an AA/EEO/Veterans/Disabled employer.