Clinical Operations Manager US - Remote
Company: Idorsia Pharmaceuticals US Inc.
Location: Cherry Hill
Posted on: November 23, 2022
The purpose of Idorsia is to discover, develop and bring more,
innovative medicines to patients. We have more ideas; we see more
opportunities and we want to help more patients. In order to
achieve this, we will develop Idorsia intoa leading
biopharmaceutical company, with a strong scientific core.
Headquarterednear Basel, Switzerland, the US Commercial Operations
& Clinical Development teams are based near Philadelphia,
Pennsylvania. Idorsia is committed to meet the changing needs of
healthcare professionals, patients, and their families. The core of
what we do is to bring creative solutions to the market based on
our science and data.
The Clinical Operations Manager drives the development of the
operational trial related documents and procedures, as well as
setting-up the External Service Providers (ESP's) and supervising
the deliverables of all ESP related activities, from specifications
to close-out. For large Phase III or complicated trials, several
Clinical Operations Managers might be assigned to a trial for the
management of ESP's.
- Manage the operational trial related activities in close
collaboration with other functions, such as: site initiations, site
closures, import/export licenses for materials and IMP, eTMF set-up
and maintenance, contracts execution and invoices, submissions to
Health Authorities, submissions to Ethics Committees/Institutional
Review Boards (ECs/IRBs), timely completion of electronic Case
report Forms (eCRFs), Source Data verification (SDV) progress and
query responses timelines.
- Manage the selection of ESPs in collaboration with other
- Lead the development of ESP specifications, testing and
implementation in collaboration with other functions, and ensure
appropriate quality control of deliverables.
- Supervise the deliverables towards the Contract Research
Organization (CRO) and ESPs selected for the trial, to ensure
compliance with study protocol and in accordance with scope of
work; identify areas of concern and escalate to the Clinical Trial
- Lead the development of trial-related operational
- Consolidate information on operational clinical trial level
activities for reporting to the CTT by the Senior Clinical
Operations Manager (including critical issues and key performance
- Resolve operational issues in a proactive and timely
- Act as the communication channel for the Clinical Research
Associates (CRAs) to ensure data quality is maintained, in close
collaboration with other CTT functions
- Approve invoices (e.g., site payments) and ensure related
payments are made in a timely manner.
- Contribute to the Study Master File (StMF) completeness and
readiness for audit/inspection and by performing ongoing quality
- Actively participate in investigator meeting preparation and
presentations and in Site Selection Visits and Site Initiation
Visits, as necessary.
- Mentor team members as needed.
- Assume responsibility for other project or trial-related duties
- Bachelor of Science degree in life sciences or healthcare
(internationally validated equivalent also considered)
- 4 years of experience managing operational aspects of Phase II
and Phase III trials and executing a wide range of clinical trial
activities from study start up to clinical study report is
- Experience in working in global cross-functional (matrix) and
- Experience in selecting and managing External Service Providers
(ESP), including performance assessments and finance
- Previous experience working with electronic data capture,
electronic Trial Master File (eTMF), and Clinical Trial Management
- Excellent knowledge of International Conference on
Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
- Strong computer skills including proficiency in Microsoft
(MS)-based applications (e.g., Word, Excel, and PowerPoint).
- Excellent verbal and written communication skills in English;
strong cultural knowledge of national diversities.
- Position may require international travel.
- Strong interpersonal, communication (written and verbal),
collaboration and organizational skills.
- Self-motivated and able to work independently and
- Goal-oriented, able to effectively prioritize and execute tasks
in a high-pressure environment.
- Demonstrate ownership and initiative, decision-making, working
flexibility and problem-solving skills.
- Demonstrate ability to work in multi-functional and
cross-functional teams: effective teamwork and collaborative
- Able to share expertise and experience with team members and
At Idorsia, we harness the power of difference, authenticity and
inclusion to achieve business success. We are committed to
fostering respect, fairness and equal opportunities for all job
applicants and all our employees. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sexual orientation, gender identity, age, national
origin, or protected veteran status and will not be discriminated
against based on disability.
Please be informed that if you are selected for this position, your
employment will be subject to a pre-employment background screening
process, of which you will be informed in greater detail in due
Idorsia operates a strictly controlled list of preferred
recruitment partners. For those partners who have no valid, signed
Master Service Agreement in place with Idorsia, please note that
all unsolicited resumes, CVs, anonymous profiles, or any other
candidate details submitted through our website or to personal
e-mail accounts of employees of Idorsia Pharmaceuticals (including
any of its subsidiaries, affiliates or related companies) are
considered the property of Idorsia Pharmaceuticals and are not
subject to payment of any form of introduction, placement or
Keywords: Idorsia Pharmaceuticals US Inc., Cherry Hill , Clinical Operations Manager US - Remote, Executive , Cherry Hill, New Jersey
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