SAS/Statistician,Medical Writer,Data Manager,Drug Safety,Clinical Scientist/Associate,Data Manager,
Location: East Hanover New Jersey
Description: TechData is at present looking to employ SAS/Statistician,Medical Writer,Data Manager,Drug Safety,Clinical Scientist/Associate,Data Manager, right now, this job will be placed in New Jersey. For detail informations about this job opportunity please read the description below. TechD ata is hiring SAS Programmer (So! me positions can be telecommute), Biostatistician, Medical Writer, Clinical Scientist, Clinical Trial Associate , Sr. Clinical Data Manager, Drug Safety Specialist for our pharmaceutical clients in Northern NJ. Please see below requirements and send your resume to: or . TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers very competitive pay rate and benefits.
Sr. Statistical/SAS Programmer:
(SOME POSITIONS CAN BE TELECOMMUTE)
Statistical Programmer with 5+ years experience supporting clinical trials in the Pharmaceutical industry. Strong drug development background and experience programming all phases of clinical trials, with NDA/submission experience. MS degree strongly preferred, in statistics/biostatistics. Experience leading statistical programming activities for drug projects and interacting with clinical project team members and statisticians. Able to write specifications a! nd be responsible for documentation. Strong technical SAS prog! ramming skills required, including comfort with all aspects of using and developing SAS macros. This position will perform significant SAS programming for protocols on a regular basis. Excellent oral and written communication skills required. - general familiarity with CDISC SDTM and ADaM - ability to work independently - project management experience
Biostatistician
DESCRIPTION OF SERVICES REQUIRED:
Designing clinical studies. Writing and reviewing statistical sections and other relevant parts of study synopses and protocols. Support study start up activities. Develop RAP, program TLFs, preparation for database lock, dry run and CSR activities; review CRF, DB spec, VAP; support analyses as required for decision making at project level; support analyses and activities during submission and response to HA questions. Coordinate study tasks with other statisticians and other line functions. Ensure timeliness and adequate quality of statistical deli! verables. Follow processes and adhere to and project standards as well as Health Authority requirements. · At least 5 years experience in pharmaceutical development and clinical research
- Strong statistical skills and knowledge of clinical trials methodology: experience with analysis planning and reporting of clinical trials
- Knowledge of SAS
- Fluent in English, good oral and written communication skills
- Experience in Oncology
- Good team player
- High degree of autonomy in performing assigned duties
- Able to establish personal relationships with personnel from other line functions
- Experience with intercultural teams
Sr. Clinical Data Manager
Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be dec! lared clean and locked according to strict performance standards. Revie! w and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preperation of protocols, CRF's and prepare or review/contribute to operations manuals. Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials. Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Travel when required. All other duties as assigned.
This individual is responsible for leading and performing Data Management (DM) Significant industry experience required - please send new candidates, rather than recycling the same candidates over and over. The manager has all previously submitted candidates and if they haven't already been selected to interview, it is unlikely that they will now. .
Qualificat! ions
- Ideal candidate should have a minimum of 5 years hands-on experience in clinical trial data management at a pharmaceutical company or CRO.
- Strong initiatives in identifying issues and proposing solutions with ongoing studies, a good investigative and meticulous approach to all activities and tasks.
- Demonstrated ability to operate independently and to influence decision-making processes within a matrix team environment.
- Must have excellent communication and facilitation skills as well as a strong proof reading background.
- Exceptional attention to detail and organizational skills required.
- Leadership ability, interpersonal and organizational skills are a must.
- Knowledge of EDC is desirable.
Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. The incumbent will provide full lifecycle support fr! om clinical study protocols through regulatory dossier preparation and ! submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator’s brochures, clinical summaries and overviews. • Assist the GMW TAH in the development of clinical document content used to support successful global clinical development, approval and marketing of a drug. • Implements the medical communication strategy for all regulatory submission documents as assigned. • Uses the Global Target Label (GTL) and all associated product strategy documents to effectively develop associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for submission dossiers used to gain marketing approval for the assigned documents. • Implements project level data presentation and messaging st! andards for the assigned documents. • Independently authors submission and study level documents (collaborating with the team) based on the strategy provided and is accountable for the format, content and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
US PV DRUG SAFETY RESPONSE SPECIALIST
The Drug Safety Response Specialist (aka Response Specialist) is the key player in the procurement of vital follow-up Adverse Event information in order to facilitate the process of case evaluation and assure compliance with regulatory authorities. The individual must have a medical background (MD, RN or other related medical background) in order to obtain, from reporters, the appropriate follow-up necessary to complete case evaluation. The individual must also possess excellent communication and organizational skills and the ability to work in a fast paced environment. Must be able to take de! cisive actions related to daily responsibilities when necessary and mus! t consistently convey professionalism when interacting with both external and internal customers.
Responsibilities include, but are not limited to:
- Monitor both the Central and LAM work lists for follow-up action item requests.
- Prepare all follow up requests from the Argus Central work list by entering them as action items in Argus LAM.
- Create the appropriate type of follow up (HCP letter, consumer letter, Clinical Trial letter etc) and assign to the appropriate individual for processing.
- Schedule re-evaluation of follow up requests to determine if required number of attempts have been fulfilled, according to and regulatory requirements.
- Generate calls and emails to consumer’s, healthcare providers and our licensed partners in order to obtain critical follow-up Adverse Event information.
- Create and email Clinical Trial letters to the study sites to request follow up information on study participants! .
- Monitor the Drug Safety Response Center mailbox for incoming requests and inquiries and initiate the appropriate process for obtaining follow up information from HCPs and consumers.
- Communicate and collaborate with Global and Local colleagues related to safety issues, clarification of requests and encourages open communication to achieve mutual understanding of issues and resolutions.
- Work cooperatively toward the identification of areas needing improvements, make valuable suggestions for improvement and develop continuous improvement methods in order to increase proficiency, accuracy and improve overall compliance within the department.
- MS degree in Life Sciences, RN plus 3 years of experience
- BA or BS degree in Life Sciences, RN, or RPh with at least 4 years
experience in PV required.
- The incumbent ! must have demonstrated problem solving skills
as described in SOPs, Operational Manuals and Guidance documents
- Experience with Medical Devices preferred.
- Experience with Obstetrics and Gynecology preferred.
Support the development of operational plans for clinical deliverables
Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects
Contribute/support the Operational CDP (O-CDP)
Create trial concept sheet.
Support development of Program Operational Plans (e.g. budget package, project-level allocation, program-level outsourcing strategy, monitoring committees, etc…).
Support the Clinical Science Unit (CSU) operationally and scientifically by ensuring development of program quality standards (e.g. collation of synopsis/protocols/CDP reviews, provide scie! ntific/medical input, advisory boards, education activities). Support development and implementation of disease/program standards.
Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
Responsible for execution of assigned clinical deliverables
Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents:
Seek external (e.g. KoL, regulatory authorities, patients associations) and internal (e.g. CSU, CPO Medical Advisors) medical/scientific input
Drive science by incorporation of innovative designs
Obtain approval from internal review boards
In collaboration with Trial Statistician, develop R! eporting and Analysis Planning (RAP) modules
Responsible to drive d! evelopment and implementation of relevant data capture toolsent
Manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards.
Responsible for the ongoing review of clinical trial data
Supports GTL to prepare database lock; and perform data reconciliation.
Support Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, GPT).
In collaboration with Medical Lead, responsible for final analysis and interpretation of results.
May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP.
Timely delivery of quality documents to support the Clinical Development Plan (e.g. concept sheets, executable synopses); as well as clinical component of regulatory documents
Execution of the trial protocol and related documents in collaboration with GTL, in complian! ce with international and local regulations and internal standards
Demonstrates excellent scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents (no avoidable amendments)
Submission of quality documents at Final Protocol Package (e.g. protocol, ICF, clinical sections of the CTA)
Applies effective clinical research methodology, including trail design/analyses, efficacy endpoints, safety assessments across disease area and development phases
Data cleaning & review
≥ 4 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
Manage several trials in parallel with multidisciplinary trial teams in a matrix organization
Strong interpersonal skills
Ability to work under pressure
Excellent negotiation and conflict resolution skills
Resolve issues with minimal! supervision and understand when to escalate
Thorough knowledge of ! Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
Demonstrates excellent scientific writing skills
Knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
Advanced degree (or clinically relevant degree) in life sciences/healthcare is required.
PharmD, PhD preferable.
Clinical Trial Associate
Assist in the operational and logistical aspects of clinical trials according to ICH-GCP and internal procedures. Assist in delegated tasks to support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.
1. Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth r! unning of clinical trials in compliance with processes. Collaborate with the CTL in taking action to address issues as they arise.
2. Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary.
3. Interactions with Investigator sites e.g. to collect relevant documentation, provision of study materials / documents.
4. Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups.
5. Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g.! internal CTL meetings or external investigator meetings. May attend an! d present at these meetings as appropriate.
6. Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary. Help check for discrepancies and take actions to correct as necessary.
7. Identify areas for process or technology improvements with regard to tasks undertaken within the role.
8. Assist in the ordering of clinical trial supplies
9. Assist in the compilation of the clinical study report and its appendices.
10. Responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.
11. Audit existing Paper Trial Master Files, collect outstanding documents and archive after study is completed.
12. Assist the CTL in organizing Investigator/Site Initiation Meetings and/or First Dose/Monitoring Visits. Attend at least 1 of thes! e meetings and assist the CTL in conducting.
13. Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.
Skills:
Fluent oral and written English
Previous experience in clinical trials (e.g. clinical trial design, execution and operations) is preferred but not required
Good organizational and interpersonal skills.
Ability to work in a team as well as independently if required and to manage multiple priorities with support.
Computer literate.
Education:
A bachelor’s degree or equivalent qualification or work experience in life sciences or nursing.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to TechData.
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This job starts available on: Wed, 13 Nov 2013 06:11:28 GMT