Parexel invites for Senior Clinical Data Analyst , PK Analyst, Clinical Data Analyst, Medical Writer, Manager-Medical Writing Services, Clinical Logistics Leader

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Posts:

Senior Clinical Data Analyst {below}
PK Analyst/Programmer
Clinical Data Analyst I
Medical Writer II
Clinical Data Analyst II
Manager, Medical Writing Services
Clinical Logistics Leader

Position: Senior Clinical Data Analyst

Key Accountabilities
* Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomy
* Act as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller projects
* Manage all phases of data management activities from study start up to database close
* Direct team members in daily activities
* Define and monitors metrics and modifies plan accordingly
* Mentor project team members
* If required, facilitate cross functional team meetings both internally and externally
* Actively review and provide feedback on study productivity
* Recognize out of scope activities and communicates to GRO Lead
* Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings / conferences
* Keeps manager(s) informed about work progress and any issues to avoid surprises. Requires minimal supervision by Manager
* Apply knowledge across multiple projects
* Define study specific processes
* Identify inconsistencies and inefficiencies in processes and recommends solutions

Skills
* Excellent interpersonal, verbal and written communication skills
* Excellent computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office products such as Excel, Word.
* Sound awareness of all relevant regulations, including GCP
* Posses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock
* Carefully weighs the priority of project tasks and directs team accordingly
* Understands the strengths and development areas of team members
* Ability to lead a *virtual*, global team as required
* Gives others appropriate latitude to make decisions
* Looks for win-win solutions to solve problems
* Ability to make appropriate decisions in ambiguous situations
* Ability to solve problems by using a logical, systematic, sequential approach
* Communicate and work effectively with clients
* Enlists the support of team members in meetings goals
* Proposes new approaches, methods or technologies
* Anticipates how others will react to situations
* Effective time management in order to meet daily metrics or team objectives
* Shows commitment to and performs consistently high quality work
* Plans and delivers verbal and written communications that persuade the intended audience
* Willing and able to travel as required
* local or international

Experience:
* Previous relevant working experience preferred, or data management, clinical and / or research experience with solid understanding of clinical trials methodology and terminology 4 Yrs. to 7 Yrs of relevant experience

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 17^th Apr, 2013
Req Number: pare-10025224

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Position: PK Analyst/Programmer

Job Description:
Key Accountabilities
* Mainly supports programming activities within the assigned clinical trial and ensures that all programming activities are executed in a timely manner and to the required high statistical and reporting standards as specified in Standard Operating Procedures (SOPs).
* Programs and documents derived datasets, listings, tables, figures and statistical appendices for pharmacokinetics and pharmcodynamics.
* Ensures that the deliveries match the agreed specifications. Supports quality control and quality audits of deliverables.
* Working according to International Conference on Harmonization Good Clinical Practice standards.
* Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
* Undertake the full range of duties relevant to the leadership, management, and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
* Other duties as assigned

Skills
* Good programming skills.
* Windows applications; Word (including adapting and writing macros); E-mail; Excel * basic; Internet; Powerpoint.
* Professional attitude; Self-motivated; Logical thinking; Attention to detail; Client liaison; Able to work independently; First time quality control; Communication of programming issues to non-technical staff.
* Excellent inter-personal, verbal and written communication skills.
* Client and quality focused approach to work.
* A flexible attitude with respect to work assignments and new learning.
* Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
* Willingness to work in a matrix environment and to value the importance of teamwork.
* Ability to work well under pressure and to keep scheduled timelines.

Education
* A 3 year degree or equivalent, in a programming discipline is preferable; Post graduate qualification is advantageous.

Language Skills
* Fluently in English

Experience:
* At least 3 years of hands on programming experience in SAS*, preferably in the pharmaceutical industry.
* Knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH).
* Basic Pharmacokinetics: Calculations and analyses (advantageous)

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Position: Clinical Data Analyst I

Job Description:
Key Accountabilities
-Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
-Conduct in-house data review
-Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
-Identify and report protocol violations
-Manual and Patient Profile review, issue queries
-Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
-Track and integrate queries
-Perform clinical coding if appropriate to role within the project team
-Ensure all documents coded for submission to central files
-Lock site(s) within EDC system - remove user's data modification privileges
-Interact with site (via mail) as required
-Perform early and final database QC activities
-Update all relevant tracking system on an ongoing basis
-Inform responsible CDA coordinator of work status regularly
-Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
-Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
-Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims

Skills
-Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, MS-Office products such as Excel, Word.
-Demonstrate a sound awareness of all relevant regulations, including GCP
-Ability to successfully work in a (`virtual) team environment
-Client focused approach to work
-If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
-Solid interpersonal, verbal and written communication skills
-Sense of urgency in completing assigned tasks
-Meticulous attention to detail
-Effective time management in order to meet daily metrics or team objectives
-Shows commitment to and performs consistently high quality work

Experience: 1 to 2 Years

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Position: Medical Writer II

Job Description:
Essential Function:
Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.

Relationships:
Reports To Departmental Line Management, Medical Writing Services
Directly Supervises None
Provides Work Direction to Medical Writer I, Associate Medical Writer, Medical Writing Assistant
Works Closely with Project Managers/Leaders Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff
External Relationships Client technical representatives

Key Accountabilities:
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates.
- Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to determine the appropriateness of content/format for clinical writing.
- Attend internal technical team and client team meetings as required.
- May provide guidance to less experienced departmental members.
- Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
- May participate in departmental or interdepartmental process improvement and training initiatives.
- May participate in development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.

Skills:
- Excellent interpersonal, verbal and written communication skills.
- Client focused approach to work.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Demonstrated understanding of the drug development process.
- Extensive clinical/scientific writing skills.
- Advanced word processing skills/familiarity with Word for Windows.

Education:
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
Language Skills:
- Fluent in written and spoken English.

Experience:
Minimum Work Experience
- Medical writing experience: experience in writing multiple clinical study reports, PSURs, informed consent, etc.

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Position: Clinical Data Analyst II

Job Description:
Key Accountabilities
* Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy
* Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
* Train team members on selected tasks
* Prepare Data Cleaning Specification
* Review the Data Validation Specification prepared by the Technical Analyst in GTS
* Develop or provide input to project specific guidelines, e.g. SAE handling.
* Initiate the running of study specific programs
* Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
* Conduct in-house data review,
* Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
* Identify and report protocol violations
* Manual and Patient Profile review, issue queries
* Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
* Track and integrate queries
* Perform clinical coding if appropriate to role within the project team
* If required liaise with 3rd party vendors to clean electronic data
* Ensure all documents coded for submission to central files
* Lock site(s) within EDC system - remove user's data modification privileges
* Interact with site (via mail) as required
* Perform early and final database QC activities
* Update all relevant tracking system on an ongoing basis
* Inform responsible CDA Coordinator of work status regularly
* Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor

Skills
* Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word
* Sound awareness of all relevant regulations, including GCP
* Ability to successfully work in a (`virtual*) team environment
* Client focused approach to work
* If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
* Effectively applies knowledge to provide advice or solutions based on expertise
* Offers support and constructive feedback to project team members
* Seeks opportunities to develop experience and knowledge
* Ability to organize and plan tasks
* Excellent interpersonal, verbal and written communication skills
* Must be able to work independently but seek guidance when necessary, escalating issues as required
* Sense of urgency in completing assigned tasks
* Meticulous attention to detail
* Effective time management in order to meet daily metrics or team objectives
* Shows commitment to and performs consistently high quality work
* Willing and able to travel as required
* local or international

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Position: Manager, Medical Writing Services

Job Description:
Essential Function
The Manager, Medical Writing Services, will research, create, and edit documents associated with the clinical sections of regulatory submissions and other clinical documents. This is a billable position (65%). The Manager is also responsible for all line management of assigned medical writing staff, either at the local site or remotely. The Manager inputs to medical writing resources for proposals. The Manager provides project management of the medical writing aspect for their projects and those of their line reports.
Relationships
Reports To Departmental Line Management
Directly Supervises Medical Writers
Provides Work Direction to Medical Writers
Works Closely with WW Senior Director, Head of WW Operations MWS, HR, Account Management, Proposals/Contracts, CRS Quality Management, MWS QM Specialist, RRC, Trainers, line managers in Biostatistics, Data Management, Medical Services, PAREXEL Consulting, Project Leaders, and Portfolio Directors
External Relationships Clients/potential clients, external consultants

Key Accountabilities
Writing and consultancy
- Prepare, review, and edit key documents for regulatory submissions without the need for any supervision or formal training. Train self to prepare any type of medical writing deliverable.
- Provide technical leadership to ensure that clinical data presented in summary documents are in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
- Advise on medical writing regulatory issues and submissions as detailed in current ICH, FDA, EMA and other applicable guidelines.
- In line with client requirements, devise and prepare medical writing deliverables for which little or no regulatory or other guidance is available, e.g., risk benefit assessment reports.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
Project management
- Be the person ultimately responsible for Medical Writing aspects of assigned projects, without supervision.
- Set clear objectives for all Medical Writing team members and monitor performance against these objectives in an ongoing way. Provide leadership and strategic re-planning, delegation of responsibilities and tasks to team members. Monitor the progress of each individual project task and assess the overall program. Monitor overall project performance in an ongoing way and if necessary identify ways to ensure that the project is completed on-time and within budget. Keep client and project team informed of study status.
- Track actual versus planned project budget for entire Medical Writing portion of project. Determine the cause of cost over-runs and out-of-scope activities and recommend corrective action to medical writing management. Identify changes in scope as and when they arise.
- Provide updates for each project to MWS manager, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements.
General management
- Attend managers meetings, and chair as invited.
- Sign off expenses/invoices/purchase orders/cheque requisitions for expenses for direct line reports, as authorised by line manager.
Line management
- Supervise and mentor assigned MWS staff, including all aspects of MWS personnel management, including hiring, training, professional development, performance development plans and annual evaluations, compensation recommendations, promotions, team building, morale, motivation, supervision of adherence to departmental QC procedures and health authority guidance and regulations, performance improvement plans, termination.
- Undertake the full range of duties relevant to the leadership, management and development of assigned staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
Process improvement
- Be familiar with all MWS Department SOPs and guidelines. Input into regular review of departmental SOPs and guidelines.
- Analyse efficiency of work and discuss improvement ideas with colleagues. Provide guidance to other members of the department on current medical writing issues and acceptable procedures.
- Attend external audits; respond to audit reports and follow-up on any issues highlighted.

Training
- Present details of technical courses attended or new knowledge acquired. Provide in-house training courses as required.
- Produce training material for and present external training courses.
- Keep abreast of new advances in medical writing and regulatory issues.
Client liaison/service
- Strive to ensure clients (internal and external) receive a quality product on time, all of the time.
- Be aware of client expectations for self and line reports. Respond appropriately to incidents of dissatisfaction, and feed back to MWS management if necessary.
- Provide support as appropriate to Account Management and MWS Management in their efforts to win new business.
- Attend business development meetings and prepare and make sales presentations to clients.
Resource planning
- Monitor resource utilization on MWS projects and compare projections to resource available.
- Maintain an ongoing understanding of departmental workload and resource availability. Use this knowledge both to identify potential resourcing problems with sufficient time to allow implementation of solutions and to indicate availability / ability to handle upcoming work to potential clients.
Proposals
- Provide input into assigned full-service client proposals. Attend proposal meetings. Estimate the hours required to complete each task. Provide a description of the medical writing services to be performed. Liaise with the proposal team and/or client to ensure that the proposal covers all services required.
- As required, co-ordinate the development of assigned standalone proposal documents, bringing together information from other departments. Estimate the hours required to complete each task. Provide a description of the medical writing services to be performed. Provide draft proposal to MWS Operational Management for review. Liaise with the client to ensure that the proposal covers all services required.

General
- Perform other tasks appropriate to a more senior position as required, with adequate support and under supervision.
- Other roles may be allocated in exceptional circumstances.
- Be able to provide short-term `basic cover for absence of other MWS management.
- Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

Skills
- Excellent interpersonal, negotiating, verbal and written communication skills.
- Professional attitude.
- Client focused approach to work.
- Client liaison.
- A flexible attitude with respect to work assignments and new learning.
- Logical thinking.
- Attention to detail.
- Self-motivated to work consistently in a fast-paced, rapidly changing environment.
- Able to work independently.
- Able to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company.
Supervision/demonstrated understanding of people management.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
- Project management (planning and monitoring).
- Business awareness/business development.
- Knowledge of resource management and productivity metric management.
- Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
- Ability to travel.

Education
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

Language Skills
- Fluent in written and spoken English.

Minimum Work Experience
- Broad experience in management of complex medical writing projects, including phase III. Previous line management experience, or equivalent, preferably in a billable service industry.

Experience:
Broad experience in management of complex medical writing projects, including phase III. Previous line management experience, or equivalent, preferably in a billable service industry.

Additional Information:
Location: Andhra Pradesh- Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 17^th April, 2013
Req Number: pare-10024363

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Position: Clinical Logistics Leader

Job Description:
Lead the Clinical Logistics Services teams by combining a depth of clinical logistics experience with insight into client pressures and an ability to develop the right solution for the client. This requires indepth business understanding in order to make effective decisions independently and the knowledge and experience required to confidently recommend a course of action. This includes providing the overall CLS functional leadership of clinical trials or clinical programs and the Clinical Logistics Services teams to achieve operational excellence; and delivering projects / programs on time, to budget, to the highest quality, compliant with ICH GCP, exceeding client expectations. This position is responsible for the profitability of managed CLS project(s) and client satisfaction.

Experience:
Educated to B.A. / B.S. or Master degree, or equivalent (e.g. Pharm.D.), in biology, pharmacy,
or other health-related discipline, international trade, business administration or logistics.
* Or relevant work experience / degree.

Seven years of pharmaceutical/clinical research/consulting industry experience.
* Experience implementing process and operational improvements.
* Previous direct experience in managing or leading clinical trial service programs or studies

Additional Information:
Location: Andhra Pradesh- Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 17^th April, 2013
Req Number: pare-10024806