Job Description
Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It's going to be an exciting future-come be a part of it!
THIS ROLE MAY BE 100% REMOTELY BASED.
Under the direction of the Executive Director, Clinical Data Management, the Associate Director, Data Management is responsible for the oversight of the data management systems and other technical capabilities in support of our Company's clinical studies including phase 1-3, post-approval, life-cycle management studies, as well as non-interventional and investigator-initiated studies. Clinical study execution will be through an outsourced operational model. This individual will play a key role in the oversight of the clinical CRO to ensure integrity of the data brought into our Company.
This position will report to the Executive Director, Clinical Data Management within Clinical Operations in the Research and Development organization of our Company's Resources Managed (budget and FTEs) Individual contributor role. This position will be responsible for the oversight of data management activities of our clinical trials conducted within Organon. Focus will be on Women's Health products and devices. Organon's current portfolio also includes biosimilars and products in other therapy areas including cardiovascular, pain, respiratory, Central Nervous System (CNS) and dermatology. The clinical operations organization is a small, nimble organization that will grow with the portfolio.
Primary Responsibilities:
Oversees data management support activities, including electronic Case Report Forms (eCRF) and database development, edit checks development, review and creation of data management documents (e.g., Data Management Plans (DMP), CRF Completion Guidelines (CCG)).
Provides support on data management activities to both internal (e.g., Clinical, Regulatory Affairs, Statistics) and external (e.g., CROs, regulatory agencies, vendors, etc.) partners.
Supports the development, implementation, and documentation of standard operating procedures (SOPs) as well as processes related to data management to ensure compliance with worldwide regulatory requirements.
Supports the selection of in-house and external data management systems and the determination of work processes.
Develops relationships with key clients and/or customers to identify emerging needs.
May provide scientific/strategic input to licensing and business development opportunities.
Education Minimum Requi rements:
Bachelor's degree, preferably in Life Sciences, Health Care, Computer Science or Engineering related discipline.
Bachelor's degree with 10+ years or MS with 6+ years experience
Required Experience and Skills:
At least 8 years' experience in Clinical Data Management.
Strong knowledge of the Drug Discovery or Drug Surveillance Process, ICH and GCP, GCDMP guidelines.
Knowledge of electronic data capture (EDC) systems, eCRF and database development lifecycle, relational databases and available tools to manage, extract, and report data.
Must have proven track record to be able to think critically, strategically, independently and problem-solving.
Must have high level of motivation, drive, and demonstration of our Company's leadership values.
Excellent written and verbal communication skills including ability to write clearly and concisely.
Ability to listen effectively and the capability to effectively communicate ideas and data both verbally and in writing in a persuasive and appropriate manner to a broad array of stakeholders.
Top notch interpersonal skills in difficult situations.
Driver of change and innovation.
Ability to work seamlessly with all levels of personnel.
Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
Excellent Word, SharePoint, Excel, Power Point, e-mail, and online meeting tool skills.
Ability to be flexible, multi-task and work independently.
Ability to work in a virtual setting/across time-zones and make effective use of communication tools (WebEx, MS Teams and video conferencing).
Experience with managing outsourced and/or licensing arrangements preferred.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
Residents of Colorado: to request this role's pay range: email: coloradopayact@organon.com
US and PR Residents Only
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID: R509264
