Manager, Clinical Data Management Resume Samples

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J Reichert

Jayda

Reichert

203 Botsford Shoal

Dallas

+1 (555) 932 7917

203 Botsford Shoal

Dallas

Phone

p +1 (555) 932 7917

Experience Experience

Houston, TX

Manager, Clinical Data Management

Houston, TX

O'Connell Group

Houston, TX

Manager, Clinical Data Management

Create, develop and maintain policies, procedures and work instructions to facilitate management of geographically distributed teams
Develops a Data Management Plan (DMP) to define the data collection and processing workflow
Develop and manage the budget for HVT Clinical Data Management according to expected standards
Coach, mentor, and develop Employees, including overseeing new Employee onboarding and providing career development planning and opportunities
Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
Leads change-management activities in order to create innovative change and best practices
Supporting Clinical Data Managers and/or Clinical Data Reviewers to ensure they have all the knowledge and tools necessary to perform their CDM/CDR duties

Los Angeles, CA

Data Manager, Clinical Data Management

Los Angeles, CA

Green and Sons

Los Angeles, CA

Data Manager, Clinical Data Management

Develops, applies and promotes consistent Data Management standards through standard processes and SOPs
Manages all aspects of case report form (CRF) design and development (paper or eCRF)
Provides support to internal and external staff in the use of Clinical Data Management systems
Assists with drafting data management verbiage for responses to proposals (RFPs) for government and private sector contracts
Provides status updates to Senior Management and Clients. Attends and leads project team meetings
Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
Acts as the Data Management Lead for multiple projects

present

Los Angeles, CA

Senior Manager, Clinical Data Management

Los Angeles, CA

Altenwerth-Rohan

present

Los Angeles, CA

Senior Manager, Clinical Data Management

present

Assist in database upgrades/migrations including performing user acceptance testing
Develop the data management plan for a clinical study
Execute the data management plan throughout lifecycle of the study
Perform training on study trial for EDC and create user guides
Provide Clinical data management support to clinical team, study projects, and biostatistics team
Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans
Ensures data system compliance by following the established guidelines of regulatory authorities

Education Education

Bachelor’s Degree in Confidentiality With Clinical Data

Kaplan University

Bachelor’s Degree in Confidentiality With Clinical Data

Skills Skills

Ability to attain, maintain and apply a strong working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Strong customer focus and excellent interpersonal skills
Solid working knowledge of clinical data management systems and processes
Ability to promote and maintain a positive and professional and positive attitude
Strong attention to detail and skill with numbers
Good written and verbal communication skills
Excellent leadership and management skills
Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level
Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner
Excellent communication (written and oral) and interpersonal skills

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15 Manager, Clinical Data Management resume templates

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Senior Manager, Clinical Data Management Resume Examples & Samples

Provide Clinical data management support to clinical team, study projects, and biostatistics team
Develop the data management plan for a clinical study
Execute the data management plan throughout lifecycle of the study
Participate in developing the case report form (CRF)
Develop database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations
Lead EDC database specification process
Develop data transfer agreement(s) between external data sources and/or labs
Reconcile electronic data transfers
Assist in database upgrades/migrations including performing user acceptance testing
Maintain/track of EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts
Perform training on study trial for EDC and create user guides
Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
Perform database lock and freeze activities
Coordinate the archiving of study databases and related documents
Perform close-out audits
Collaborate with IT and implementation team(s) to address clinical application requests and/or changes to clinical database systems
Ensures data system compliance by following the established guidelines of regulatory authorities

Manager, Clinical Data Management Resume Examples & Samples

Conducts all CDM role responsibilities in support of clinical study teams and as defined in policies and procedures
Collaborates with Clinical Study Team to create protocol case report forms (CRF)
Designs Electronic Data Capture (EDC) databases to collect and process CRF data; may include coordination with EDC vendors and programmers to deliver a validated system
Performs User Acceptance Testing (UAT) of the EDC database
Develops a Data Management Plan (DMP) to define the data collection and processing workflow
Conducts data processing and review in accordance with the study protocol, DMP, and EDC system instructions
Generates standard and ad hoc reports of EDC CRF or metric data for study team and management reporting
Coordinates the development of Case Report Forms or EDC forms with clinical and biostatistics groups
Provides data management expertise on Agensys clinical study teams
Performs database lock activities to ensure the accuracy and completeness of final clinical trials databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries
Participate as a clinical study team member and contribute to team deliverables to include protocol design, site EDC training, and study conduct activities through completion of the study report
May include performance of Quality Control checks for study documents and data output
Performs additional duties as needed in support of clinical study teams or department activities
15 + years of relevant experience are required without a BA/BS, or BA/BS with typically 7+ years relevant experience, or typically 5+ years with Masters degree or typically 2+ with Ph.D. or equivalent
2+ years experience in data management, clinical research in the pharmaceutical industry required
Must be familiar with the global data operations of Agensys
Highly experience with database management software, MS word, and MS Excel is required
Highly experienced with the management of Medidata RAVE or other EDC systems is required
Must have demonstrated project management skills
Effective communication and organizational skills
LI-EP

Manager, Clinical Data Management Resume Examples & Samples

Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatistics, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting
Ensures completeness, accuracy and consistency of clinical data and data structure across all projects
Responsible for putting together highly effective CDM teams and delivering a clear sense of direction
Design and uses all available vehicles for effective scientific communication with and outside the company
Anticipate moderately complex obstacles and difficulties for clients and acts upon them in order to meet team goals
Addresses Regulatory Submission issues within Biometrics and with other related departments
Working knowledge and experience with PMDA regulations and inspections § Experience with web-based Electronic Data Capture (EDC), preferably Medidata RAVE
Familiarity with clinical data management systems and industry wide thesauri, such as MedDRA, WHO Drug, J-Drug, etc
Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level
Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner
Anticipates internal resource needs and external costs for the short and long term. Works with senior management and HR to ensure long-term resource allocation within a therapeutic area
Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues
Leads initiatives to gather, organize, and analyze interim clinical data from various data sources, such as Virology, and examines issues from various perspectives
Assist the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
7 years of experience and a BS degree
5 years of experience and a MS degree
3 years of experience and a PhD. As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster

Manager Clinical Data Management Resume Examples & Samples

Acted as a team lead on a multi-person team, not necessarily in data management
Strong attention to detail and skill with numbers
Strong analytical/problem-solving skills
Ability to work in a team environment and independently as needed
Ability to forecast project resourcing and hours needed. Ability to review utilization and make decisions/adjustments as necessary

Manager, Clinical Data Management Resume Examples & Samples

A minimum of a Bachelor’s degree in the biological sciences, Computer Science or related discipline, with at least 8 years of related experience, including 6 years of clinical data management experience in Medical Device or Pharmaceuticals is required
A minimum of at least 1 year of supervisory experience is required
History of leading project teams to deliver excellent quality results is required
Excellent verbal and written communication skills is required
Knowledge of GCP, CDASH/CDISC and regulatory requirements regarding clinical data management documentation and software is preferred
Experience with Electronic Data Capture (EDC) is required
Experience with Medidata RAVE is preferred
Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug) is preferredClinical Data Management

Group Manager, Clinical Data Management Resume Examples & Samples

LI-LC1
Minimum of 6 years of data management experience
Minimum of 2 year supervisory experience
Excellent analytical/problem-solving skills
Ability to attain, maintain and apply an excellent level of knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Ability to effectively manage and motivate others

Manager, Clinical Data Management Resume Examples & Samples

Minimum of 5 years of data management experience
In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global Standard Operating Procedures and client expectations
Ability to use interactive computer programs
Ability to attain, maintain and apply a strong working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Ability to supervise and delegate tasks
Must be able to set and meet, for self and team, timelines or be able to recognize and schedule changes in response to project demands

Program Manager, Clinical Data Management Resume Examples & Samples

Develops data integrity, risk mitigation and action plans and oversees execution when appropriate
Support study-level audit and inspection readiness activities as needed
10+ years relevant work experience with a focus on data management
Deep understanding of drug development and biopharmaceutical industry required
High attention to detail including proven ability to manage multiple, competing priorities
Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs

Manager, Clinical Data Management Resume Examples & Samples

Develop high-quality professionals
Assess and monitor CDM activity and resources
Work closely with Clinical Affairs, Regulatory Affairs and other cross-function partners
Create, develop, maintain and enforce policies, procedures and work instructions to assure the efficient and effective collection of clean, reliable clinical data
Create, develop and maintain policies, procedures and work instructions to facilitate management of geographically distributed teams
Develop training plans and assure adequate training of all internal and external CDM staff
Assure that all CDM activities are based on industry best practices and satisfy all applicable regulations and guidances as well as Edwards Policies and Procedures
Develop and manage the budget for HVT Clinical Data Management according to expected standards
A minimum of 10 years experience and a Bachelor’s degree or higher: computer science, life sciences or a related field or a Master’s degree with 8 years experience
Experienced in programming and data management in a clinical or related health-care setting
Experienced in software platform evaluation and selection
Experienced supporting cross-functional, distributed teams
Managerial experience and people skills to lead a diverse team of professionals
Working knowledge of current industry best practices and regulatory requirements for regulated clinical trials including validation, patient privacy and data exchange formats

Manager, Clinical Data Management Resume Examples & Samples

Minimum 10 years of clinical data management experience in a either pharmaceutical, biotech, or CRO environment
BS BA or equivalent experience within the industry
Solid working knowledge of clinical data management systems and processes
Effective communication skills, both oral and written
Ability to give presentations and training sessions
Ability to travel for client meetings and bid defense
Proven ability to build, manage and foster a team-oriented environment
Excellent communication (written and oral) and interpersonal skills

Senior Manager Clinical Data Management Systems Resume Examples & Samples

Doctorate degree & 2 years of directly related experience
Master’s degree or equivalent in computer science, data analytics or data science, business administration or related discipline
5+ years work experience in life sciences or a medical related field
Strong leadership skills demonstrating the ability to champion new ideas and challenge the conventional mindset and status quo in order to bring to life improved methods of clinical system support
Deep understanding of clinical development and data management activities in order to understand the importance of data flow, data relationships, and corresponding system technologies (e.g. Rave, Oracle (Data Management Workbench), CTMS systems, Coding Tools, etc…)
Proven credibility in leading technical system deliverables such as system integrations (Web Services), complex application/platform upgrades, and/or spearheading troubleshooting efforts to correct and/or prevent system or clinical data related risks
Managerial experience, responsible for direct line staff reports and thus accountable for performance reviews, staffing/resource inquiries, coaching and mentoring, and being a strong advocate for career growth
Exemplary customer service skills, as demonstrated in being able to pivot quickly to emerging or changing business requirements while leveraging business relationships to maximize product delivery
Seasoned knowledge and experience in the use of performance management techniques (e.g. Six Sigma, KPI, KCIs, etc..) to effectively manage external vendors
Candidates must have excellent communication and listening skills to stakeholders, stakeholder community, and fellow system peers in order to make thoughtful decisions, which will advance system solutions, influence directional positions, and address risks
Be highly self-driven with a strong work ethic focused on results and high-quality outputs
Expertise in vendor management and resource management, used to assess workload capacity and monitor functional responsibilities
Support Global Site operations by providing unparalleled devotion and tireless commitment to the upkeep and sustainability of Data Management Systems
Accountable for activities related to the technical components of a clinical trial as it is related to Data Management and Site Operations
Promote innovation, by acting as a strong advocate for automation and the advancement of new technologies to streamline services
Be a central POC for Global Network and Continuous Improvement (AFP) strategies including successful launches in medical health devices (mHealth), Shared Investigator Portal, CTMS, and Clinical Data Repositories
Leverage deep understanding of business processes to search for new methodologies and technologies which will drive efficiency, quality, and compliance
Act as a subject matter expert, be a single point of contact and escalation source for system related issues and development activities
Advance Data Management technical capabilities through refinement of existing processes and use new technology to develop prototypes to drive forward efficiency, map data relationships (i.e. trending, correlations), and adapt to changing business landscapes
Be an accountable and respectful manager to all direct line staff reports by being resourceful, helping to address challenges/bottlenecks, providing superior coaching /mentoring, supporting staff career growth, and ensuring adherence to standard procedures

Asso Manager, Clinical Data Management Resume Examples & Samples

Minimum 3-5 years’ experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry, supervisory or management experience is preferred
An overall working knowledge of the drug discovery or Drug Surveillance process, ICH and GCP guidelines
Strong communication skills (oral and written) with the ability to communicate with both the technical and business areas
Demonstrated project management, decision making and problem-solving skills
Ability to establish effective professional relationships across a wide range of business contacts
Ability to build talent and lead team with influencing skill and development skill
Ability to work under pressure in a changing environment with flexibility

Senior Manager, Clinical Data Management Resume Examples & Samples

Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document
Report query trends and data/query metrics
Participate in the development of EDC custom report specifications as needed
Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
Address the business needs of CDM functional customers

Data Manager, Clinical Data Management Resume Examples & Samples

Manages/supports the data quality and data management activities at the project or study level in support ofthe overall operation and business need
Manages/supports data management related timelines and resources. Coordinates deliverables within the overall project team timelines. Ensures all project data management deliverables meet the pre-defined criteria and timelines
Acts as the Data Management Lead for multiple projects
Reviews protocols and Statistical Analysis Plans (SAP)
Manages all aspects of case report form (CRF) design and development (paper or eCRF)
Develops specifications for standard edit checks, data listings, and reports
Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
Reconciles electronic data transfers from vendor to Sponsor
Leads and coordinates database and web site QC processes
Reviews data for accuracy, completeness, and consistency
Trains junior team members on all data management tasks such as the processes to track and resolve queries, and the reconciliation of Protocol Deviations and Adverse Events
Communicate with clinical sites and external vendors on data related tasks
Provides status updates to Senior Management and Clients. Attends and leads project team meetings
Provides support to internal and external staff in the use of Clinical Data Management systems
Oversees and supports the development of Data Management Plans (DMPs), data entry instructions and guidelines, coding manuals, and other data documentation manuals
Develops data standard conventions and guidelines and ensures they are applied consistently across projects
Develops, applies and promotes consistent Data Management standards through standard processes and SOPs
Along with other PMs and CDMs, leads the effort to improve KAI’s best practices, Standard Operating Procedures, and internal standards for data management
Leads and supports therapeutic/disease specific common data element development and implementation
Supports FDA CDISC submission
Assists with drafting data management verbiage for responses to proposals (RFPs) for government and private sector contracts
Bachelor's degree in life sciences or related field; Master’s degree in a health-related field or Statistics preferred
Minimum 3+ years of data management experience, and CDM certification preferred; some biostatistics knowledge preferred; SAS programming is a plus
Project management experience is a plus
Strong understanding of clinical trial data; good understanding of relational database components and theory; knowledge of XML is a plus
Well-versed in all aspects of data management and clinical IT systems from study start-up to database lock
Experience with Electronic Data Capture systems and commercial Clinical Data Management Systems
Knowledge of GCP, ICH, and FDA regulatory requirements as they apply to clinical data management
Knowledge of CDISC standards and the therapeutic/disease specific common data elements; hands-on experience using these standards (i.e., CDISC, NCIP caDSR, etc.) is a plus
Proficient in Microsoft Office (Word, PowerPoint, Access)
Mastery of Microsoft Excel
Ability to lead small and large project meetings
Self-motivated, detail-oriented, with strong analytical and problem solving skills
Excellent verbal and written skills, good organizational, interpersonal, and team skills
High energy with ability to work on multiple studies, to complete deliverables on time, and to adjust priorities in a fast-paced environment

Manager, Clinical Data Management Resume Examples & Samples

Accountable for staff development: critiques, instructs, mentors, evaluates, and coaches. Ensures staff is appropriately trained in processes and procedures; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors
Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis
Manages processes to ensure data integrity via appropriate data management processes (e.g., protocol compliance reporting, querying for missing or discrepant data, evaluating data outliers, performing data quality checks, etc.)
Manages custom query requests and reporting from clinical databases (i.e., Oracle Clinical, etc.) made by the Clinical department and other departments
Provides other departments with queries from clinical databases as necessary (e.g., Development, Marketing, etc.)
Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding changing regulations that affect clinical studies. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Bachelor's Degree in Computer Science, Informatics, Health Sciences, or related field
Minimum of eight years of progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry
Prior leadership experience that includes managing direct reports
Must be able to apply the fundamental clinical data management concepts and practices to conduct needs assessment, research and develop information for market development purposes
Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc
Ability to work effectively within a team in a fast-paced changing environment
Ability to multi-task, prioritize and meet deadlines in timely manner
Strong organizational, planning, and follow-up skills and ability to hold others accountable
Ability to travel approximately 20%, including internationally
An advanced degree in a relevant discipline
Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, related programs
Knowledge of clinical research, and experience in managing Investigational Device Exemption (IDE) clinical data

Manager Clinical Data Management Resume Examples & Samples

To provide supervisory functions for a team of allocated staff within the CDM department including training and mentoring
To support HR and CDM management with the hiring, discipline and discharge of staff as necessary
To perform performance appraisal and ongoing staff development for direct reports
To ensure that all data management activities are conducted in line with regulatory guidelines, SOPs, and client expectations, ensuring that projects are completed on time, accurately and within budget
Provide regular and timely communication with colleagues in other functional groups
To identify potential out of scope activities to Project Managers and CDM management and assist with the contract modification process

Manager, Clinical Data Management Resume Examples & Samples

People Management
Forecasts and manages local subfunctional resources within global resourcing database to ensure studies and non-study tasks are adequately resourced
Contributes or leads local/global and cross-/subfunctional working groups and initiatives
Leads or participates in the global and local functional/cross-functional implementation of best practices and process improvement initiatives to ensure efficiency
Leads change-management activities in order to create innovative change and best practices
Performs select program-level activities for molecules when a program data leader is not assigned to ensure continual of process
Developing overall CDM strategy
Promotes CDM operational excellence in order to facilitate knowledge sharing and creating an environment of continuous improvement
Contributes to and manages components of the local CDM budget to ensure resource allocation
Contributes to the development and implementation of manager best practices in order to have an efficient and effective team
Ensures the PD, Biometrics and CDM mission, vision, values and goals are understood and that individuals are clear on how they contribute to them
Develops and maintains collaborative working relationships within CDM and cross-functionally in order to support staff and to benefit the overall CDM organization
Reviews CDM metrics to ensure subfunction operational efficiency

Manager, Clinical Data Management Resume Examples & Samples

Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work
Provides or arranges for project specific training for CDM team members
Monitors quality of work performed by CDM project team; coaches staff where necessary
Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
Ensures quality timely delivery and consistency of clinical data and data outputs across all assigned projects
Ensures CDM project documentation is in an audit-ready state
Author and review company documents such as SOPs, WIs, Forms, and associated documents affecting CDM
Maintains positive working relationship with internal customers and vendors
Identify potential solutions to project and staff issues and assist leadership to promote a positive, productive, and collaborative team
Perform job responsibilities with a high level of accuracy and quality, and within established timeline
Minimum of 8 - 10 years’ experience in clinical data management in progressive roles of leadership
Demonstrated ability to translate project plans into goals and objectives for own function
Demonstrated leadership skills and ability to effectively prioritize own group's activities for development projects and clinical trial performance
Ability to identify and develop operating guidelines and procedures
Management experience of CROs, Vendors and Consultants preferred
Experience using commercial clinical data management and/or EDC products (e.g. Medidata Rave, Inform, Oracle Clinical/RDC, etc.)
Previous work in rare diseases is highly desirable
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
Strong computer skills including knowledge of Microsoft Office Suite
Demonstrated comprehension of medical terminology

Manager, Clinical Data Management Resume Examples & Samples

Coaching staff to assure compliance to customer and internal requirements, specifically data management processes and procedures, for assigned projects
Assures equal distribution of work across each Clinical Data Manager/Reviewer
Conducting performance reviews for all direct reports
Coaching, counseling and disciplining direct reports
Initiating, coordinating and enforcing systems, policies and procedures
Conducting new hire interviews
Strong organizational and leadership skills
Ability to promote and maintain a positive and professional and positive attitude
Fluency in English (both verbal and written) is required
Experience as a Lead Data Manager within a CRO or pharmaceutical environment or other relevant positions utilizing a project and/or data management skillset is required
7+ years working in an Electronic Data Capture environment
7+ years of data management or experience working with clinical trials and/or within pharmaceutical or clinical environment
Understanding of clinical trial terminology
Proven ability in analyzing data
Experience working with computer software including MS Office

Manager, Clinical Data Management Resume Examples & Samples

To supervise the data management set-up activities for each assigned project
To provide accurate project metrics and resource information at the request of CDM management, and to effectively use this information to manage progress of assigned projects
To allocate clear responsibilities within the data management study team for each assigned project to enable all targets to be met. Delegate tasks to team members as appropriate, providing guidance and support as necessary
Manage project forecasting of hours and identify resource requirements
Participate in the development and implementation of processes, procedures and training for the data management function as directed
To participate in business development activities, assisting with bid preparation and by representing data management at bid defense meetings. Additionally, promote repeat business by developing relationships with existing sponsors

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