We're expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we're hiring a Senior Manager of Data Management in Mexico!
In this role, you will manage the day-to-day activities of the Data Management (DM) function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans, with an emphasis on effective resourcing and development of personnel.
The Senior Manager is responsible for the successful planning, implementation, and execution of DM contracted activities. The Senior Manager provides oversight, leads activities for data management projects, and coordinates inter-departmental and client communication. This person will support the Head of Department in the development of functional training, hiring, definition of standards, and execution of department goals including process improvement.
Essential functions of the job include but are not limited to:
- Supports the DM Lead as the point of contact for internal team and sponsor, ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner for all studies for clients, which may include DM oversight of sponsor programs
- Line manages, directs, leads, develops, and supervises data managers
- Support the LDM in the management of contractual and financial aspects of project
- Reviews Request for Proposals (RFP), proposals, change orders, and provide project estimates
- Oversees project data entry process for paper studies, including development of data entry guidelines, training, data entry quality and resourcing
- Ensure DM adheres to project timelines. Provides input, assesses, and may manage timelines. Ensures that clinical data management deliverables are met with quality
- Assesses resource needs for assigned projects, as needed
- Ensures the DM Leads successfully plans, organizes, and coordinates data management (DM) activities in a set of projects belonging to one or more clients, meeting quality, timelines, and budget expectations
- Accountable for ensuring all data quality and timeliness of DM deliverables are met and aligned with the business goals
- May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May conduct database build UAT and maintain quality controlled database build documentation
- Oversees overall quality of the clinical database
- May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
- Oversees completeness of data management documentation for the Trial Master File
- May train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
- May run patient and study level status and metric reporting. Oversee the development requirements and frequency of report delivery
- May coordinate SAE/AE reconciliation
- May liaise with third-party vendors, such as external data and EDC vendors, in a project-manager capacity in support of timelines and data-related deliverables
- May partner with cross-functional stakeholders to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting and serving as an internal expert on data management/RBQM with vendors
- Develops and supports customer relationships, manages customer expectations, and flags/escalates risks as required
- Identifies, troubleshoots and strategizes operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- Participates in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May be a subject matter expert in one or more DM/system topics, creating training on the SOPs/processes
- Provides technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior reflect PfM principals
- Responsible for managing, leading, and mentoring staff. Collects timely feedback and conducts performance evaluations. Participates in the interview process for new recruits
- Supports Business Development teams by attending strategy meetings, bid defense preparation meetings, bid defenses, capability presentations, potential client engagement, professional meetings or seminars
- Reviews Request for Proposals (RFP), proposals, provide project estimates
- Provides leadership for cross-functional and organization-wide initiatives, where applicable
- Ensures that all data management project team members have been sufficiently trained
- Communicates with sponsors, vendors and global project teams as needed regarding data, database or other relevant project issues, and is responsible for developing, maintaining, managing, and meeting client expectations
- May present software demonstrations/trainings, department/company training sessions, and presents at project meetings
- Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards
- May require some domestic and international travel
- May perform other duties as assigned
Qualifications:
Minimum Required:
- A minimum of 8 years of DM experience and 3 years of line management experience
- Bachelor's degree with direct clinical trial experience in a CRO or Pharmaceutical environment
Other Required:
- Previous experience in managing people within a scientific/clinical background is preferred
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong leadership and interpersonal skills
Preferred:
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
- Oncology and/or Orphan Drug therapeutic experience
Skills:
Competencies
- Embodies the key precision principles: Client service, purpose, accountability, mutual respect and collaboration
- Ability to work independently, manage time and create plans to achieve people, revenue and business goals
- Ability to work effectively with minimal direction; must be a self-motivated and self- directed individual who enjoys a challenging and dynamic work environment
- Team player willing to collaborate and share knowledge
- Effective leadership , communication, interpersonal and negotiation skills
- Exceptional customer service orientation and proven track record of successful client relationship management
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
- Conveys thoughts in a clear, concise, and accurate manner. Provides appropriate status on all work and projects
- Embraces a standard of excellence and a rigorous adherence to laws and regulations which govern our industry
- Sets a personal example of what is expected of others. Functions as an opinion leader and appropriately influences others. Willing to take informed risks within the scope of respective roles
- Takes ownership of problem resolution. Adequately engages in due diligence, seeks input from others and makes informed and sound judgments as appropriate
- Maintains positive relationships with colleagues. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people
- Knowledge of the clinical research process from Phase I through regulatory submission
- Strong knowledge of data governance, data quality, data integration, and data security principles
- Proficiency in data management tools and technologies
- Strong analytical and problem-solving abilities
- Familiarity with data privacy and compliance regulations
- Project management skills and experience in leading cross-functional teams with respect to project management
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