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Job Description

The** **Position

The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in the operational aspects of phase 1 & phase 2a studies and will report to the Executive Director, TMED Operations. The CTM will support the TMED Operations Lead to plan and execute studies including, but not limited to, managing study timelines, reviewing/approving study-related documents and serving as the primary point of contact for study vendors. The CTM will also assist to manage the clinical study team and help to coordinate meetings and interactions with vendors to optimize communication and execution of TMED studies.

Responsibilities

+ Manage and support the operational aspects of clinical studies from study start-up through close-out.

+ Manage and serve as the point of contact for study-related vendors, including the study contract research organization (CRO) and/or clinical study sites or other vendors, as appropriate, to execute TMED studies in accordance with contracted scope, costs and timelines.

+ Actively engage with vendors on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities.

+ Coordinating internal and external cross-functional communication and documentation to optimize collaboration and ensure TMED studies are executed with the highest standards and are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.

+ Identify risks to ensure successful execution of TMED studies, proactively communicate risks to internal and external cross-functional teams and vendor teams, and manage the clinical study team to develop and implement risk mitigation strategies and tactics to enable study completion in accordance with approved timelines and plans.

Tasks

+ Attend and actively participate in assigned clinical study teams and vendor meetings.

+ Oversee vendor and CRO performance, ensuring deliverables are met within scope, budget, and quality standards.

+ Engage and communicate effectively with study site personnel and investigators.

Competencies

+ Phase 1 study operations

+ ICH/GCP

+ Clinical research

+ Clinical development

+ Vendor selection and management

Required Education, Experience and Skills

+ Bachelor’s degree or higher in natural or health sciences (pharmacology, biology, nursing, or related sciences).

+ Excellent organizational and project management skills to facilitate optimal clinical study team and/or sub-team functioning and cross-functional collaboration.

+ Working knowledge of GCP, ICH and other regulatory standards.

+ Skillful at technical writing with an ability to precisely and accurately summarize clinical and scientific information in written format.

+ Track record of effective functional representation on product development teams.

+ Excellent verbal and written communication skills.

+ Collaborative mindset with a positive, transparent and inclusive approach as a representative or leader of cross-functional team(s).

+ Functional capability with various software platforms including Microsoft Word, PowerPoint, and Excel.

+ A minimum of five to six years-experience in translational medicine and early clinical development within the pharmaceutical or biotech industry with a proven track record for competence and efficiency in overseeing the execution of TMED (early phase 1 – 2a) studies.

+ Experience supporting the early development function by contributing to SOP working groups and other process-related teams and/or sub-teams.

+ Experience in Women’s Health is strongly preferred.

Secondary Language(s) Job Description

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.

US and PR Residents Only

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OFCCP Pay Transparency Rule

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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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.

**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$103,100.00 - $175,300.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

**Requisition ID:** R536677