Clinical Trials Disclosure Mgr
2 weeks ago
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
Roles & Responsibilities:
- Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
- Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
- Support trend analysis and continuous improvement initiatives
- Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
Required Skills:
- Experience understanding and interpreting data/information and its practical application
- Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
- Working experience with disclosures on public registries e.g.
- Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
- Good communication skills including excellent spoken and written English
- Ability to follow controlled processes
- Leadership skills, including ability to teach, negotiate and influence
- Project management skills, including ability to prioritize work in order to meet required deadlines
- Problem solving ability
- Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
Basic Qualifications:
- Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
- Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
- Minimum of 2 years experience in preparation of regulatory documents for public disclosure
- Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
.-
Manager, Clinical Trial Disclosure
3 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 15,00,000 - ₹ 20,00,000 per yearWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Manager, Clinical Trial Disclosure
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time US$ 80,000 - US$ 1,20,000 per yearWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Clinical Trials Coordinator
6 days ago
Hyderabad, Telangana, India beBeeProgram Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Global Clinical Operations Program Manager RoleThis position offers the opportunity to become a key member of our clinical operations team, overseeing and coordinating early modeling viability assessments, global feasibility assessments, recruitment projections, and allocation strategies for assigned trials and programs.About The RoleThe ideal candidate will...
-
Clinical Trial Coordinator
7 days ago
Hyderabad, Telangana, India beBeeClinical Full time ₹ 8,41,000 - ₹ 12,49,000Job Title:Clinical Trials CoordinatorWe are seeking a skilled professional to support the management of clinical trials. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions in various systems.Main Responsibilities:Assignments: Be assigned to one or more projects under...
-
Associate Clinical Trial Leader
4 weeks ago
Hyderabad, Telangana, India Thepharmadaily Full timeJob DescriptionResponsible for supporting, under the guidance of the Lead Clinical Trial Leader and/or Clinical Trial Leader (CTL) and the Clinical Program Leader (CPL), all aspects of TCO clinical trial(s) as assignedMajor accountabilities:- May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight...
-
Clinical Trials Coordinator
4 days ago
Hyderabad, Telangana, India beBeeResearch Full time ₹ 6,00,000 - ₹ 8,00,000About Our Clinical Trial OpportunityOur organization is seeking a seasoned Clinical Research Coordinator to spearhead clinical trial activities at our site. As a critical member of our team, you will ensure seamless execution of study protocols and compliance with regulatory requirements.Key Responsibilities:Coordinate and manage day-to-day clinical trial...
-
Clinical Trial Manager
1 week ago
Hyderabad, Telangana, India beBeeResearch Full time ₹ 9,00,000 - ₹ 12,00,000Job Title: Senior Clinical Research CoordinatorKairos R and D Solutions Pvt. Ltd. is a fast-growing organization dedicated to providing high-quality clinical trial services.We are seeking an experienced Clinical Research Coordinator to join our team in Hyderabad.Main Responsibilities:Manage day-to-day clinical trial activities at the site.Ensure compliance...
-
Clinical Trial Supply Manager
2 days ago
Hyderabad, Telangana, India NOVARTIS Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Description SummaryClinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.The CTSM is the GCS single point of contact at trial level for the respective core CTT (Clinical trial team) and/or CTT Sub-Team they...
-
Clinical Trial Supply Manager
4 weeks ago
Hyderabad, Telangana, India Novartis Full timeJob Description SummaryClinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.The CTSM is the GCS single point of contact at trial level for the respective core CTT (Clinical trial team) and/or CTT Sub-Team they...
-
Clinical Trial Supply Manager
2 weeks ago
Hyderabad, Telangana, India Novartis Full timeJob Description Summary Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.The CTSM is the GCS single point of contact at trial level for the respective core CTT (Clinical trial team) and/or CTT Sub-Team they...
