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Makro Technologies 
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Job Search Results: Jobs 1 - 5 of 5  View Titles Only  Page 1 of 1
Title   Company Name     Location   Date  
Clinical Research Scientist 

  Makro Technologies    Worldwide   28/11/2006 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Regulatory Affairs  
Education: Bachelors   Position type: Full Time Executive  Experience: 4 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Regulatory Affairs, Research  
Full Requirement : Complete Description: Drafts protocols, formulates requirements for clinical supplies and develops CRFs.As a Clinical Research Scientist, you will participate in preparation of routine clinical documents (i.e. protocols, CRFs, GMRs, ICFs, etc.). You will prepare complex documents with moderate supervision and routine documents independently as directed by supervisor ( AHT, CAP, CDP, IND documents, etc.). You will evaluate and select potential investigative sites with minimal to moderate supervision. You will organize and present complex aspects of protocol design at investigator and internal meetings. You will also conduct initiation/monitoring visits independently, coordinate and monitor activities at clinical/investigational sites with minimal supervision by medical monitors and/or project monitors. You may also participate in training/mentoring new hires. You will oversee and coordinate the collection of and/or collect pre-study documents independently. You will monitor safety with minimal to moderate supervision via any of the following: telephone contacts, study event reports, case report form/safety report reviews, contacts with regional clinical associates (RCA), RCA monitoring trip reports, or direct site visits. You will also participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and may serve as Study Team Leader as well as a member of a broad range of CR&D-related and ad hoc committees as needed. You may represent organizational unit at research-wide meetings and on committees, including Global Clinical Project Teams and Interdepartmental Project Teams. In addition, you will serve as a clinical science resource for the team(s), and for peers and/or subordinates.  
Qualification & Skills:A BS or equivalent with a minimum of 5 years related experience or a MS degree or equivalent in Life Sciences with a minimum of 4 years related experience is required. You must have good interpersonal skills. You must have the ability to work with and negotiate with colleagues to find solutions to resource/supplies/timeline issues.  
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Clinical Program Manager 

  Makro Technologies    All   28/11/2006 
Category: clinical trials  
Education: Bachelors   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Regulatory Affairs, clinical trials  
Full Requirement : The Manager Clinical Programs is a member of the Clinical Team and manages the planning and feasibility of execution of clinical trials performed as part of the Clinical Development Plan. The incumbent is responsible for ensuring that the clinical programme can be executed in line with the overall clinical development strategy. The technical/functional environment is the clinical team. The position may work on one or more projects. Participates as a member of the Clinical Team Attends and/or chairs all project/clinical team meetings as appropriate. Manages the planning and feasibility of execution of clinical trials performed as part of the Clinical Development Plan and contributes to Clinical Study Design. May be responsible for more than one clinical project/trial, depending on project scope and individual experience. Defines project standards where necessary to ensure consistency within global projects. Builds effective relationships internally and externally. Manage information on project performance from all team members (including CROs), alerting the Clinical Team Leader and project team to any potential time slippage. Facilitates resolution of problems affecting the achievement of clinical project milestones. Remain current on trends in individual therapeutic area by attendance at conferences and review of publications  
Notes and Comments: BS or equivalent qualification/experience 3-5 years experience in vaccinology/clinical research Formal training in GCP methods Proven track record in delivering high-quality GCP-compliant Clinical Trials. International (ie. more than 1 regulatory environment) Clinical Trial experience preferred Knowledge of Code of Federal Regulations and regulatory agency documents Good interpersonal skills ability to work with individuals at different levels Independence, self-motivation Strong team worker Resourcefulness; ability to find solutions to operational problems  
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Clinical Data Manager 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, data management  
Education: Bachelors   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research  
In this role, you will handle detailed Data Management issues for all Phases of clinical trials (Phase 1-4) including oversight of CRO data Management activities.

Additionally, you will participate in study planning and initiation data activities (e.g., CRF design, database design, annotated CRF, and edit check/Data Management Plan development in conjunction with the clinical study team ensuring application of Cubist data standards.

You will also ensure the accuracy, completeness, and consistency of clinical databases, carry out safety and microbiology data loading/transfer procedures, prepare materials for NDA vendors, actively participate in the NDA and e-submission process, prepare ad hoc data listings and review analysis tables, listings, and figures for consistency and accuracy.

Moreover, you will be expected to work closely with lead study and Project managers to develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met, as well as develop and SOPs, departmental guidelines, data standards and other activities to support DM and biostatistics as needed.

Top candidates for this position will have a minimum of a BS/BA in a scientific discipline or equivalent, a minimum of 5 years experience as a Data Manager in a CRO or Pharmaceutical/Biologics/Medical Device company, and experience as a lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials).

Demonstrated experience with a data management system (e.g., Clintrial or Oracle Clinical), ability to work interdependently with minimal supervision, and excellent written and oral communication skills are required.

Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries is necessary;

Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental;

Familiarity with ICH GCP as well as general knowledge of industry practices
and standards (CDISC, SDTM) are essential.
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Associate Director, Quality Control 

  Makro Technologies    All   28/11/2006 
Category: QA - Quality Control, Clinical Research, quality control  
Education:   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Biochemistry, GLP, GMP, Information Systems, Quality Assurance, Quality Control, Regulatory Affairs  
Full Requirement : As an Associate Director for QC, you will be responsible for managing and assuring the continued compliance with GMPs for the QC laboratory operations, as well as the development, implementation and maintenance of Quality Control testing, and the systems and activities within the Quality Control areas for analytical testing, lab support, cell biology and method development. You will oversee the development and implementation of standards, methods, and procedures both for inspecting, testing and evaluating the precision, accuracy and reliability of the company's products and for supporting GMP compliance within the company's manufacturing facilities. You will also oversee laboratory operations including investigations, deviations, validations and troubleshooting, as well as review SOPs, reports and submissions. Additional responsibilities will include participating in regulatory discussions, strategies for CBER submissions, providing information and reviews for technical content, and leading discussions and interactions with inspectors and regulatory contacts. You will be responsible for the training, performance and career development of Quality Control staff, including evaluating staff performance and recommending merit increases, promotions, and probations to Human Resources and to the Director, QC. You will also oversee the administration of company personnel, health and safety, and hazardous materials policies, as well as prepare and manage the budget for the department.  
Qualifications 6-10 years experience in a regulated biologics cGMP manufacturing industry.Technical protein chemistry experience, QC lab method development, validation, raw material program management, utility testing and monitoring, including wet chemistry, biochemistry and biological assays. Experience with FDA inspections, regulatory authorities, regulatory submissions. Experience in a cGMP Compliance oriented environment. Working knowledge of FDA, cGMP, EP/JP and ICH guidelines. Strong oral and written communication skills. Computer skills with MS office and familiarity with SAP and LIMS database beneficial.BS, MS in Science and experience in the regulated industry  
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Sr. Principal Biostatisticians 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, Medical Equipment  
Education: Masters   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Biostatistics, Clinical Data Management, Clinical Research, Regulatory Affairs  
Full Requirement : Responsible for all statistical tasks on the assigned clincial trials, e.g. clinical trial design/planning, analysis plan, reporting activities including programming tasks, exploratory analyses and additional analyses to support publications. Write statitical methodology section of protocol, statistical section of clinical trial report and review clinical trial report. Oversee CRO deliverables for trials contracted out. Minimum requirements MS in Statistics with at least 6 years of pharmaceutical experience or PhD in Statistics with at least 2 years of experience for Sr. Prinicipal Biostatistician. Solid, hands-on experience as a lead statistician in protocol development, analyses, study reports, for Phase II-III clinical trials. Strong statistical skills and good knowledge of SAS. Good knowledge of drug development process. Project management skills. Experience in supporting clincical development plan and/or NDA submissions. Experience participating in internation teams. Very good oral and written communication and negotiation skills.  
Phd/MS in Statistics
Required years of experience Five - Seven Years in Pharma or Biotech industry  
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