CLINICAL RESEARCH VACANCY

Asian Clinical Trials (ACT) a division of Suven Life Sciences Limited

ACT invites applications for the following positions:

CLINICAL RESEARCH OPERATIONS

PROJECT MANAGER

POSITION SUMMARY

Provide overall project management of clinical trials or clinical programs. General areas of responsibility include:

• Project feasibility assessment and initiation
• Resource procurement and planning
• Project implementation
• Leading and motivating a cross-functional project team
• Milestone planning and tracking
• Ensuring that projects are conducted in accordance with GCP, SOPs, ICH and/or other guidelines to fulfill local regulations
• Production of key project progress reports and metrics
• Responsible for management of and communication between ACT Project team and sponsor, contract and financial management

Primary role:

• Manage Phase II -IV domestic, international or global projects
• Participate in proposal development teams
• Represent project management at marketing/new business meetings
• Represent ACT at professional meetings
• Provide leadership, training, and mentoring to clinical operations group

QUALIFICATIONS

Education:
Graduate or post graduate degree in life sciences, nursing or other health related science (For e.g. BSc, MSc, BPharm, MPharm and MBBS, MD)

Minimum Work Experience:

• 4 or more years of relevant work experience recommended
• 2 or more years as a lead CRA/Clinical team leader.
• 1 or more years of Project Management or Management experience recommended, (includes time spent as functional Primary or functional/technical Lead)

Preferred Skills:

• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegation, drive and time/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients as well as within ACT, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment
• Business/Operational skills that include customer focus, commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, strong written and oral communication skills
• Computer literate
• Proven analysis and negotiation skills
• Demonstrated ability in the following areas: critical reasoning skills including
  the identification and resolution of complex problems, supervisory and planning skills, excellent communication skills, both verbal and written, effective teamwork through coaching and mentoring, highly effective interpersonal skills, high level of initiative; ability to work independently and collaboratively on project teams, interface with investigative sites, and recognize safety and efficacy data trends.
• Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable, willing to travel 10-25% of the time.

CLINICAL TEAM LEADER

POSITION SUMMARY

Provide site management of multiple clinical trials or clinical programs. General areas of responsibility include:

• Site feasibility assessment and initiation

• Tracking of enrollment of study subjects.

• Ensuring that sites are conducting the study in accordance with Protocol, GCP, SOPs, ICH and/or other guidelines to fulfill local regulations

• Responsible for management of and communication between ACT Project team and investigator, ACT and vendors

Primary role:

• Is overall responsible for the management of all sites for the study in which he/she is the lead CRA.

• Ensuring that the study related documents are up to date at the site and in house.

• Develop monitoring plan, provide input to the PM, oversee the creation of and reviews and maintains TMF

• Coordinate Ethics Committee submissions and Regulatory Authority applications and approvals

• Provide leadership, training and mentoring to junior project team members and assist in the management of the clinical project team, delegate various responsibilities.

• Provide sponsor with a point of contact in the absence of the PM.

QUALIFICATIONS

Education:

Graduate or post graduate degree in life sciences, nursing or other health related science (For e.g. BSc, MSc, BPharm, MPharm and MBBS)

Minimum Work Experience:

• 2 - 3 years of relevant work experience recommended

• 2 or more years as a CRA recommended, which should include extensive monitoring activities.

Preferred Skills:

• Good written and verbal communication skills in English.

• Computer literacy: MS Office

• Attention to detail

• An understanding of the ICH-GCP, CFR and local regulatory guidelines

• Demonstrated ability in the following areas: reasoning skills including the identification and resolution of problems, supervisory and planning skills, excellent communication skills, both verbal and written, effective teamwork through coaching and mentoring, effective interpersonal skills, initiative; ability to work independently and collaboratively on project teams, interface with investigative sites, and recognize potential problems and resolve them.

• Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable, willing to travel 10 – 25% of the time.

CLINICAL RESEARCH ASSOCIATE

POSITION SUMMARY

Provide site management of clinical trials or clinical programs. General areas of responsibility include:

• Site feasibility assessment and initiation
• Monitoring of sites and tracking of enrollment of study subjects.
• Ensuring that site are conducting the study in accordance with Protocol, GCP, SOPs, ICH and/or other guidelines to fulfill local regulations
• Completion of site visit reports and metrics
• Responsible for management of and communication between ACT Project team and investigator.

Primary role:

• Site monitoring of Phase I-IV domestic, international or global projects
• Ensures that the study related documents are up to date at the site and in house.

QUALIFICATIONS

Education:
Graduate or post graduate degree in life sciences, nursing or other health related science (For e.g. BSc, MSc, BPharm, MPharm and MBBS)

Minimum Work Experience:

• 1 - 2 years of relevant work experience recommended

Preferred Skills:

• Good written and verbal communication skills in English.
• Computer literacy: MS Office
• Attention to detail
• An understanding of the ICH-GCP, CFR and local regulatory guidelines
• Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable, willing to travel 40 -50% of the time.

CLINICAL DATA MANAGEMENT

CLINICAL DATA MANAGER

POSITION SUMMARY

This position is responsible to ensure the projects are conducted as per the SOPs, ICH GCP and standard guidelines.

Implement and execute project ensuring the final deliverables are delivered within time lines without compromising on the quality.

Contribute to the Data Management functional group objectives by leading and progressing initiatives to improve working practices and procedures

Primary role:

• Participate in theCRF design/review process and validation of CRF database setup


• Planning and Execution of the CDM projects including:


• Assist in developing data validation checks and create test data and scripts for validation programming.


• Assume responsibility for the issuance and implementation of DCFs, Medical Coding using MEDdra, generation of study progress reports and maintenance of data management documents.

QUALIFICATIONS

Education:

Graduate or post graduate degree in life sciences, nursing or other health related science (For e.g. BSc, MSc, BPharm, MPharm and MBBS, MD)

Minimum Work Experience:

• A minimum of 3 years of data management experience in clinical trials with increasing responsibility and international exposure, as well as demonstrated ability to perform Clinical Data Management tasks.

Preferred Skills:

• Ability to successfully manage and motivate a team


• Ability to strategically plan and execute with a result orientation


• Ability to think globally


• Ability to manage projects to successful completion


• Flexible to anticipate and adjust for roadblocks or problems


• Ability to work with DM team for synergy and integration

DATA VALIDATION ASSOCIATE

POSITION SUMMARY

• Ensure that data entered by Data entry operator is complete and accurate so that the results are error free
  
• Ensure that all the discrepancies (i.e., Manual, Univariate, Multivariate, Indicator) have resolved and accurate data is collected to achieve required quality of data expected from sponsor or client.
  

Primary role:

• Requires minimal oversight to perform daily activities.
• Ensure the completeness and validity of the clinical trial data that has gone through data entry.


• Review and resolve discrepancies identified by the system or through manual checks as per guidelines.


• Propose data clarification forms to clinical trial sites.


• Evaluate the database quality for studies either on an ongoing basis or after patient database is locked


• Perform quality evaluation on selected patients.


• Prepare quality indices and submit to Project Manager.


• Mentor new DVAs to perform editing.

QUALIFICATIONS

Education:

Graduate or post graduate degree in life sciences, nursing or other health related science (For e.g. BSc, MSc, BDS, BPharm, MPharm and MBBS, MD)

Minimum Work Experience:

• 4 or more years of relevant work experience recommended
  
• 2 or more years as a Data Validation Associate
  

Preferred Skills:

• Good analytical and logical skills


• Personal qualities that include the ability to gain trust and confidence with a variety of clients as well as within ACT, good learning ability, action oriented and resilience in a fast-paced and rapidly changing environment


• Operational skills that include customer focus, commitment to quality management and problem solving


• Good team player


• Effective communication skills that include the provision of timely and accurate information to stakeholders, strong written and oral communication skills, computer literate: MS Office


• Proven analysis and negotiation skills


• Demonstrated ability in the following areas: critical reasoning skills including

the identification and resolution of complex problems, planning skills, excellent communication skills, both verbal and written, effective teamwork through coaching and mentoring, highly effective interpersonal skills, high level of initiative; ability to work independently and collaboratively among teams, interface with investigative sites, and recognize safety and efficacy data trends.

• Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable.

3. PROGRAMMER-Oracle Clinical

POSITION SUMMARY

This position will plan and coordinate database design, development, implementation and maintenance.

Primary role:

• Manage Phase I -IV domestic, international or global projects


• Participate in database design, testing, and programming tasks of the Clinical data management
  

QUALIFICATIONS

Education:

Graduate or post graduate degree in Computer Science or related field with relevant work experience, knowledge of Oracle is required, languages required are SQL and PL/SQL

Minimum Work Experience:

• 1 - 2 years of relevant work experience using Oracle Clinical.

Preferred Skills:

• Good written and verbal communication skills in English.


• Programming skills using SQL


• Attention to detail


• An understanding of the ICH-GCP, 21 CFR part 11 and local regulatory


• Attributes: Self-motivated and motivational, self-starter, positive team player.

4. SENIOR BIOSTATISTICIAN

POSITION SUMMARY

The Biostatistician may serve as lead biostatistician on one or more projects. Prepare analysis plans and write detailed specifications for analysis files, consistency checks, tables, and figures. Conduct statistical analysis utilizing SAS software. Interpret analyses and write statistical sections of study reports.

Primary role:

• Protocol Development- Study Design, Selection of end points, Sample Size, Randomization procedure


• Communicate with clients regarding statistical analysis issues as they arise
  
• Conduct statistical analysis utilizing SAS software
  
• Interpret analyses and write statistical sections of study reports
  
• Interact with staff from other operational groups, e.g.,clinical, medical data management
  
• May serve as Project Manager on small Statistical Operations project
  
• Where deemed necessary or appropriate, the biostatistician may also serve the
  role of statistical programmer
• Report/Manuscript Writing

QUALIFICATIONS

Education:

Ph.D. degree in Statistics or Biostatistics; or Masters Degree in Statistics or
Biostatistics

Minimum Work Experience:

• 4 or more years of relevant work experience recommended
  

Preferred Skills:

Familiarity with moderately complex statistical methods that apply to Phase 1-IV clinical trials

Strong working knowledge of SAS

Pharmaceutical drug development, biotech or CRO industry experience is a plus

Must be able to demonstrate good verbal and written communication skills

Excellent attention and accuracy with details

Strong organizational skills and multi-tasking abilities

Strong individual initiative, commitment to teamwork and quality

CONTACT:

Asian Clinical Trials
5F Serene Chambers
Rd #5 Avenue7 Banjara Hills
Hyderabad 500034, India
or
Email to : career@act-india.com