Associate Director, Clinical Data Management - Animal Health
Associate Director, Clinical Data Management - Animal Health
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
Job Overview:We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity consistency and confidentiality of data collected during laboratory challenges and clinical field trials. This role involves close collaboration with numerous stakeholders such as Clinical Research Associates Statisticians Quality Assurance and Regulatory Affairs to drive data excellence and enhance the efficiency of our clinical research operations.
Key Responsibilities:
Lead Data Management Initiatives:Direct the development and maintenance of comprehensive databases designed to collect and retain clinical data pertinent to laboratory challenges and clinical field trials for veterinary pharmaceutical and biologic compounds.
Integrity Checks:Develop and execute comprehensive edit checks to maintain the integrity and consistency of data.
Discrepancy Management:Collaborate with Clinical Research Managers to resolve complex data entry discrepancies and differences effectively.
Data Analysis and Reporting:Partner with Clinical Research Managers and Clinical Research Assistants to analyze data findings troubleshoot issues through effective data queries and communicate results with Investigator sites.
Data Tracking and Transfers:Manage the tracking and seamless transfer of external data to the primary database or data warehouse systems.
Innovative Process Development:Drive the development and implementation of innovative processes to enable paperless studies through an Electronic Data Capture system.
Stakeholder Collaboration:Foster cooperative relationships with a diverse range of stakeholders including medical researchers veterinarians project managers and regulatory affairs professionals to achieve project goals.
Key Attributes:
Proven ability to lead and manage comprehensive data management processes.
Skilled in implementing and optimizing Electronic Data Capture systems.
Familiarity with CDISC CDASH/SDTM standards for data collection and reporting.
Proficient in database entry systems.
Strong knowledge of GCP and GLP.
Thorough understanding of clinical research and clinical trial methodologies.
Strong regulatory knowledge including FDA/CVM EMA/CVMP and VICH guidelines.
Excellent strategic planning and execution capabilities.
Exceptional interpersonal negotiation and communication skills.
Proficient in delivering impactful presentations to diverse audiences.
Required Experience:
Bachelor of Science (or international equivalent) in Data Management Management Information Systems (MIS) Biological or Clinical Sciences or a related field.
Minimum of 5 years in the pharmaceutical industry specifically within a data management capacity.
At least 2 years of demonstrable experience in a people management role.
Expertise in Prelude software or similar dedicated data management applications.
Comprehensive understanding of regulatory regulations and company procedures.
Ability to work independently while contributing positively to a project team environment.
Proficient in English with excellent verbal and written communication skills.
Proactive flexible and capable of performing well under pressure.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$139600.00 $219700.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
05/7/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
