Director, Data Management - Plymouth Meeting, United States - Organon

Description

Job Description

Job Description

The Position

Reporting to Associate Vice President of Clinical Data Sciences (AVP CDS), the Director of Data Management will play a critical role in shaping and executing data management strategy and execution. The Director of Data Management will provide clinical data management expertise and leadership and be responsible for developing and implementing Data Management processes consistent with regulatory requirements and best industry practice across clinical programs. This individual will oversee data management vendors, perform in-house data management activities as applicable, and ensure high-quality completion of databases and data deliverables in close collaboration with cross functions.

Responsibilities

• Provides strategic and technical expertise in clinical data management for clinical development programs and regulatory submissions.
• Implements processes (e.g., SOPs and WIs) and standards consistent with regulatory requirements and best industry practice for Data Management function.
• Evaluate and select clinical data management vendors; manage vendor and in-house data management activities for clinical trial data collection to ensure quality and timely deployment.
• Oversee identifying, locating, evaluating and validating data management documents and databases required for report generation or regulatory submission.
• Generate data listings or other data review tools for reporting of study metrics.
• Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data.
• Manages and lead data management 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)), coordination of medical coding, monitoring of data cleaning performed by CROs.
• Ensure that database updates, data reconciliations between EDC and other sources, and ongoing data entry and cleaning are reasonably current to enable high-quality data snapshots and data locks.
• Ensures that database lock activities are completed per project timeline while adhering to established Data Management processes to achieve high quality data deliverable with proper documentation and inspection.
• Ensures adequate staffing of all program and study teams and coordinates requests for support from other departments including hiring, promotion, transfer and/or release of staff and management.
• Ensures that Clinical Data Management interfaces effectively with other Departments.
• Anticipates new challenges, risks, and needs for Data Management, and proactively mitigates to ensure business continuity and quality.

Required Education, Experience and Skills

• B.A. or B.S. degree or higher, preferably in a scientific area or health related discipline.
• A minimum of 12 years' experience in Clinical Data Management in pharma or biotech.
• Five or more years of leadership experience.
• Expert knowledge (including at least 12 years of experience) of industrial leading electronic data capture (EDC) systems, eCRF and database development lifecycle, relational databases and hands on experience with available tools to manage, extract, and report data.
• A broad, comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.
• Extensive experience (including at least 12 years of experience) managing data management vendors and performing in-house data management activities, as applicable.
• Strong expertise (including at least 12years of experience) in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry.
• Strong knowledge of the ICH and GCP, GCDMP guidelines, and CDISC standards.
• Ability to collaborate, communicate and interact effectively in a fast-paced team environment.
• Excellent interpersonal and communication skills both written and verbal.

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.

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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)

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

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:

Requisition ID:R525209