Please glance through our latest openings.  The list below is only a selection of our openings. We conduct confidential searches for our clients as well as partner with other recruiters on their unadvertised positions.

Clinical Data Entry Specialist  

Position Summary: We are seeking Clinical Data Entry Specialist for contract positions. Individuals must be well organized and have excellent communications skills with an analytical mind.

Qualifications: At DZS, your values, abilities, and track record of success are more important than direct experience. That being said, an ideal candidate would have the following:

Recent clinical data entry background

1+ year clinical research experience

 Strong typing and MS Office skills

Must be detail-oriented

Experience updating clinical database is preferred

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

Clinical Data Manager

Manages and supports team of Data Management professionals to efficiently produce databases that meet customer requirements.

Responsibilities:

• Manage a team of professional Data Management staff.  Size of team could vary from 2-5 , depending on the Data Management Function.
• Define and prioritize resource requirements and manage resource assignments across projects.
• Directly responsible for utilization of staff.
• Assess and document competency of staff to satisfy position responsibilities.  Regularly set goals and evaluates and documents performance.
• Propose salaries, promotion and termination actions.
• Actively contribute to recruitment of new staff.
• Implementation of department/office objectives.
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
• Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
• Identify and address professional development/training needs of staff.
• Mentor staff members to develop Data Management process, system, and drug development expertise.
• Provide operational input into proposals and scope of work. Participate in proposal defenses.
• Attend customer meetings and lead discussions of project requirements and strategic planning.
• Understand scope of work, budget, and scope assumptions.
• Identify out of scope work and provide revised costs with supporting documentation.
• Ensure project milestones are met according to agreed upon timelines.  Actively manage quality throughout project.
• May be Project Manager/Project Lead for a major study or a series/group of studies

 A degree in clinical, biological or mathematical sciences or related field, or nursing qualification with a minimum of 5 years of relevant work experience. Advanced knowledge of Data Management processes and systems. Technical programming skills may be required. Outstanding written and oral communication skills are required. Solid understanding of clinical drug development process is preferred.Proven leadership skills. Previous people management experience is preferred. Excellent organizational skills and demonstrated ability to manage projects. Experience in effectively managing multiple tasks simultaneously. Effective problem solving skills.

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

Project Associate /CRO
Location : New Jersey
Full Time Contract

This position provides support for projects according to SOPs and GCP. The successful incumbent assures the implementation of project plans as assigned.


Responsibilities:

 
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Interact with internal work groups to evaluate needs, resources and timelines.
• Execute the scheduling and tracking of internal and external training plans as assigned
• Interface with investigative research sites and sponsor representatives in accordance to study specific plans
• Provide project support as a liaison between the Clinical Operations team and the investigative research sites
• Provide support to investigative research sites: set-up, training, protocol questions, data management and patient safety issues.
• Review and route study data to investigative sites according to data management plan.
• Update, track and maintain study-specific trial management tools/systems.
• Knowledge of IRB regulations and submissions (informed consent, etc).
• Set-up and maintain study files (study specific, investigator, etc).
• Attend investigators’ meetings, project team meetings and teleconferences, as needed.
• Other duties as assigned by management.

Education / Qualifications:
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or the equivalent combination of education, skills and experience to perform the job
• Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.
• Basic understanding GCP.

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

 

Senior Biostatistician

The Senior Biostatistician is responsible for providing statistical support, including study design, sample size and protocol development in support of clinical trial projects. Prepares statistical analysis plans, generates statistical summary tables and listings and performs database integration for more comprehensive analyses.

1. Prepares statistical analysis plans, timelines for statistical project management and performs and interprets basic and complex analyses. Utilizes knowledge of statistics and medical understanding to propose and perform additional analyses when appropriate.

2. Documents analyses, creates summaries and presents written and verbal results to requestors.

3. Writes statistical text for study reports and clinical publications.

4. Identifies potential data problems from analytic queries and takes appropriate actions to guide the resolution process.

5. Collaborates with principal investigators, sponsors and external representatives to ensure that project results and conclusions are presented accurately and without bias and to jointly achieve objectives and timelines.

6. Provides quality review on statistical analysis plan to ensure consistency with protocol and adequacy to meet objectives defined in protocol.

7. Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics.

8. Provides consultation to the clinical research project team on statistical issues related to the project.

9. Collaborates with statistical programmers that support clinical projects to identify potential data problems from analytic queries and to take appropriate action to guide the resolution process.

10. Performs other related duties.

DZS  is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds.

Job Qualifications:

Excellent written, oral and interpersonal skills

Demonstrated analytical and problem solving skills

Excellent organizational skills

Detail-Oriented 

4 years of biostatistics or related experience in clinical research 

MS Word and Excel - Advanced 

SAS or similar application - Advanced 

MS Outlook - Basic

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

Sr. Clinical Trial Manager

We have an immediate need to hire a contract full time Senior Clinical Operations Manager to oversee, execute and report on clinical trial operations of multi-center studies.

 

Job Responsibilities:

Act as the primary interface with clinical investigator teams and research coordinators

Manage clinical research strategy and the clinical study design.

Implement approved clinical trial protocols and operational plans.

Manage resources and timelines for study start-up activities.

Manage the site clinical coordinators and study support personnel.

Ensure development of study documents (i.e. informed consent forms, CRFs, site selection materials, investigator updates, etc.).

Ensure clinical research projects are compliant with applicable regulations, guidelines, and corporate policies (FDA, OUS Regulatory and SOPs).

Position Requires:

Bachelors Degree and a minimum of 5 years of clinical project/trial management / clinical operations management industry experience.

Must have the ability to establish and maintain systems and processes necessary to control and report trial status and activities.

Must be able to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.

Experience leading project teams through the start-up, trial conduct, data management, and report generation.

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

 

Clinical Data Manager

The assignment is with a pharmaceutical client and it would be a 3 month contract initially, open to both freelancers or through a fixed term contract The contract is due to start October 2010

 

Activities to include:

• Data Cleaning/Query Management
• Review and Verification of answered Queries
  Performing Data Reviews
• Writing manual queries according to Data Validation Plan
• Programming/Creation of Listings/Reports for Manual Reviewer

To be eligible for consideration you should be:

• Degree level in Life Sciences
• Previous Clinical Data Management experience in pharma/CRO
• Experience with EDC systems
• Fluent in English
• In possession of full eligibility to work in US

Email your CV to: kward@clinplus.com with a suitable time to contact you.

Senior SAS Programmer

Primary Duties:

As a Senior Programmer, you will provide statistical programming expertise in the production of tables, figures and listings, quality control, the import/export of data and the creation of derived SAS datasets.

You will assist in the programming tasks for the Data Management team, assisting with definition of database and set up data entry screens, set up systems for study processing and prepare electronic data for export while preparing any documentation for return at the study completion.

Qualifications:

Candidate must have at least 5 years of SAS programming experience in supporting clinical trials; possess high level of expertise in SAS/BASE, SAS/STAT SAS/GRAPH, SAS/SQL, MACRO, ODS, SAS REPORT and SAS/CONNECT areas; and be proficient in data manipulations, report/graph generations using data steps with varies SAS functions, procedures, macros, and ODS facilities; must be experienced with production of data listings, summary tables and graphs for completion of Clinical Study Report and have good understanding of statistical methodologies and clinical trial operations.

• Candidate will provide statistical programming expertise in SAS in the production of analyses, tabulations, graphics, and listings from clinical trial data.
• Key responsibilities and skills include, but are not limited to the preparation of statistical analysis plans. Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
• Contribute to the integrated clinical/statistical report and other similar documents.
• Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Perform quality assurance procedures on work performed by others.
• Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities.
• Assist in the integration of data from remote entry sites, contract research organizations and co-licensing partners to the central database.
• Provide statistical programming expertise in SAS for the production of analyses, tabulations, graphics, and listings from clinical trial data.
• NDA experience and/or knowledge of FDA regulations are preferred.
• Proven ability to organize workload, priorities and complete tasks on time.
• Demonstrated ability to work effectively in a team environment.
• Strong interpersonal skills and ability to communicate effectively.
• Ability to identify and solve technical problems. Education: BS/MS in statistics, mathematics, or computer science. MS in statistics is preferred. SAS Institute certification is highly desirable.

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

Contract SAS programmer.

Main responsibilities

Responsible for ensuring quality and accuracy of programming deliverables
Reports to the Biostatistical Programming Manager
Responsible for adhering to policies, SOPs and other controlled documents

Key Activities

Write, test and validate software programs to produce and analysis datasets and Tables Listings Graphs
Perform QC checking of software programs written by another programmer
Manage software development, testing
Interface with§ outsourcing partners
Contribute to the continuous improvement of Global  Biostatistics and Development
Perform such duties as are reasonably requested by line management

Benefits

Flexibility working - After the first 6 months contract
Energetic environment
Ability to contribute and add benefit
Expand your knowledge
The successful candidate will have a broad career experience within the pharmaceutical sector having at least 5+ years career as a Pharmaceutical Programming expert . Please only apply if you hold the requested criteria

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

Senior Clinical Data Manager

Provide specialized knowledge and detailed attention to lead and carry out data management data review activities in support of one or more clinical research studies.
The position is responsible for:

• Working within clinical study teams as an extended team member.
• Defining project timelines and executing the clinical data management operations against them, and any other priorities.
• Using defined department metrics as a framework for timely and quality clinical data management deliverables.
• Collaboration with peers within and outside the organization to pro-actively manage data availability and integration.

Requirements

• Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 8 years experience, BS/BA degree with 6 years experience, or MS degree with 4 years experience.
• Minimum 3 years experience in a project lead role within a clinical data management organization, preferably within medium-large pharma or CRO.
  Ability to travel 15%

Email your CV to: kward@clinplus.com with a suitable time to contact you.

 

 

Senior Clinical Medical Coding Specialist.

Summary:

• Provides consistent and accurate coding using standardized dictionary terminologies coding group.
• Provides quality review of coding performed by the coding group, independent contractors or other third-party vendors (e.g., CROs) ensuring medical coding uniformity, accuracy, and consistency.
• Manages assigned project timelines and prioritization of tasks.
• Ensures compliance with regulations and coding guidelines.
• Assists with updates and maintenance of medical dictionaries and synonym lists.
• Provides input to coding processes, standards, and guidelines ensuring consistent implementation of procedures and standards.
• Supports coding related projects and resolution of dictionary or coding related issues.
• Maintains a clinical understanding of medical terminology, clinical research development, safety processes, adverse event reporting, and standardized dictionaries.
• Represents the end-user community on system team’s supporting clinical data coding activities.
• Provides training of new coders and other staff as related to coding and coding dictionaries (e.g., MedDRA, WHO DRUG)

Roles:

Candidate will function as a Study Medical Coder, Study Medical Coding Reviewer, Subject Matter Expert, Dictionary Oversight Committee Chair, and Dictionary Manager

Education:

• Degree or equivalent experience in a Health or Health Science related field (e.g., RN, RPh): BS/BA degree with 6 years of relevant experience, or MS degree with 4 years experience.
• Minimum 3 years of experience within a coding organization, preferably within medium-large pharma or CRO.
• Ability to travel 5%

Email your CV to: kward@clinplus.com with a suitable time to contact you.