Uncategorized - MITCON BIOPHARMA

Clinical Research Associate (CRA)

Job Summary: A Clinical Research Associate (CRA) is responsible for monitoring and managing clinical trials to ensure compliance with regulatory requirements and study protocols.

Key Responsibilities:

Monitor clinical trial sites to ensure compliance with study protocols, GCP (Good Clinical Practice), and regulatory requirements.
Conduct site visits, including pre-study, initiation, monitoring, and close-out visits.
Review and verify accuracy of clinical data and ensure proper documentation.
Liaise with investigators, site staff, and study sponsors to ensure smooth conduct of trials.
Assist in the preparation of regulatory submissions and ethical review board applications.
Report and follow up on adverse events and protocol deviations.

Qualifications:

Bachelor’s degree in life sciences, nursing, or a related field.
Prior experience in clinical research or a related field.
Strong understanding of ICH-GCP guidelines and clinical trial processes.
Excellent organizational and communication skills.
Willingness to travel extensively.

Clinical Research Manager

Job Summary: A Clinical Research Manager oversees the planning, execution, and management of clinical trials to ensure they meet regulatory and ethical standards.

Key Responsibilities:

Develop and manage clinical trial budgets, timelines, and resources.
Supervise and mentor clinical research staff, including CRAs and coordinators.
Ensure compliance with GCP, regulatory guidelines, and company SOPs.
Liaise with regulatory authorities, ethics committees, and external vendors.
Oversee the preparation of clinical study reports and regulatory submissions.
Monitor trial progress and resolve issues that arise during the study.

Qualifications:

Master’s degree in life sciences, pharmacy, or a related field.
Extensive experience in clinical research and trial management.
Strong leadership and project management skills.
In-depth knowledge of regulatory requirements and clinical trial processes.
Excellent communication and problem-solving abilities.

Clinical Trial Coordinator

Job Summary: A Clinical Trial Coordinator is responsible for the administrative aspects of clinical trials, ensuring they run smoothly and efficiently.

Key Responsibilities:

Coordinate and manage logistical aspects of clinical trials.
Maintain and update trial documentation, including regulatory and ethics submissions.
Schedule and organize investigator meetings and site visits.
Assist in the recruitment and training of trial participants.
Monitor trial supplies and manage inventory.
Communicate with investigators, sponsors, and CROs (Contract Research Organizations).

Qualifications:

Bachelor’s degree in life sciences or a related field.
Experience in clinical research or a similar administrative role.
Strong organizational and multitasking skills.
Proficiency in MS Office and clinical trial management systems.
Good communication and interpersonal skills.

Clinical Research Scientist

Job Summary: A Clinical Research Scientist designs, conducts, and analyzes clinical trials to evaluate the safety and efficacy of new drugs or medical devices.

Key Responsibilities:

Develop clinical trial protocols and study designs.
Analyze clinical trial data and interpret results.
Prepare clinical study reports and publications.
Ensure compliance with regulatory standards and GCP.
Collaborate with cross-functional teams, including medical, regulatory, and biostatistics.
Provide scientific input and expertise to support clinical development programs.

Qualifications:

PhD in life sciences, pharmacology, or a related field.
Strong background in clinical research and data analysis.
Experience with regulatory submissions and clinical study design.
Excellent analytical and scientific writing skills.
Ability to work collaboratively in a team environment.

Drug Safety Associate

Job Summary: A Drug Safety Associate is responsible for monitoring and evaluating the safety of pharmaceutical products throughout their lifecycle.

Key Responsibilities:

Collect, assess, and report adverse drug reactions and safety data.
Conduct pharmacovigilance activities in compliance with regulatory requirements.
Maintain and update safety databases.
Assist in the preparation of safety reports and regulatory submissions.
Collaborate with medical and regulatory teams to address safety concerns.
Participate in safety monitoring committees and meetings.

Qualifications:

Bachelor’s degree in pharmacy, nursing, or a related field.
Experience in pharmacovigilance or drug safety.
Knowledge of regulatory requirements for drug safety reporting.
Strong attention to detail and analytical skills.
Excellent communication and organizational abilities.

Pharmacovigilance Specialist

Job Summary: A Pharmacovigilance Specialist ensures the ongoing safety of pharmaceutical products by monitoring and assessing adverse events.

Key Responsibilities:

Conduct risk assessment and signal detection activities.
Prepare and review periodic safety update reports (PSURs) and risk management plans (RMPs).
Analyze safety data and identify trends and safety signals.
Provide safety input for regulatory submissions and product labeling.
Collaborate with clinical, regulatory, and medical teams on safety issues.
Ensure compliance with global pharmacovigilance regulations and guidelines.

Qualifications:

Advanced degree in life sciences, pharmacy, or a related field.
Extensive experience in pharmacovigilance and drug safety.
In-depth knowledge of regulatory requirements and safety assessment methodologies.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.

Pharmacovigilance Manager

Job Summary: A Pharmacovigilance Manager oversees the pharmacovigilance activities within a company to ensure the safety of its products.

Key Responsibilities:

Manage the pharmacovigilance team and activities.
Develop and implement safety management systems and procedures.
Oversee the preparation of safety reports and regulatory submissions.
Ensure compliance with global pharmacovigilance regulations.
Conduct safety assessments and risk evaluations.
Liaise with regulatory authorities and other stakeholders on safety issues.

Qualifications:

Master’s degree in life sciences, pharmacy, or a related field.
Significant experience in pharmacovigilance and safety management.
Strong leadership and project management skills.
Comprehensive knowledge of global regulatory requirements.
Excellent communication and interpersonal skills.

Clinical Data Coordinator

Job Summary: A Clinical Data Coordinator manages the collection, organization, and quality control of clinical trial data.

Key Responsibilities:

Coordinate the data collection process for clinical trials.
Ensure the accuracy and completeness of data entry and documentation.
Perform data cleaning and validation activities.
Assist in the development of data management plans and CRFs (Case Report Forms).
Communicate with clinical trial sites to resolve data discrepancies.
Prepare data reports and summaries for review.

Qualifications:

Bachelor’s degree in life sciences, information technology, or a related field.
Experience in clinical data management or a similar role.
Proficiency in data management software and databases.
Strong attention to detail and organizational skills.
Good communication and problem-solving abilities.

Clinical Data Manager

Job Summary: A Clinical Data Manager oversees the data management process for clinical trials, ensuring data integrity and regulatory compliance.

Key Responsibilities:

Develop and implement data management plans and protocols.
Oversee data collection, entry, and validation processes.
Ensure the accuracy and completeness of clinical trial data.
Manage data management teams and activities.
Collaborate with clinical, biostatistics, and regulatory teams.
Prepare and review data reports and regulatory submissions.

Qualifications:

Master’s degree in life sciences, information technology, or a related field.
Extensive experience in clinical data management.
Strong leadership and project management skills.
In-depth knowledge of data management software and regulatory requirements.
Excellent analytical and communication skills.

Clinical Data Analyst

Job Summary: A Clinical Data Analyst analyzes clinical trial data to support the development and approval of new drugs and therapies.

Key Responsibilities:

Perform statistical analysis of clinical trial data.
Generate data summaries, tables, and graphs for reports and publications.
Collaborate with biostatisticians and clinical researchers on data interpretation.
Ensure data accuracy and integrity throughout the analysis process.
Contribute to the development of data analysis plans and protocols.
Provide data analysis support for regulatory submissions.

Qualifications:

Bachelor’s degree in biostatistics, life sciences, or a related field.
Experience in clinical data analysis and statistical methods.
Proficiency in statistical software (e.g., SAS, R).
Strong analytical and problem-solving skills.
Excellent communication and teamwork abilities.

Regulatory Medical Writer

Job Summary: A Regulatory Medical Writer prepares clinical and regulatory documents to support the approval and marketing of pharmaceutical products.

Key Responsibilities:

Write and edit clinical study reports, protocols, and regulatory submissions.
Ensure documents comply with regulatory requirements and guidelines.
Collaborate with clinical, regulatory, and scientific teams.
Prepare documents for ethical review board and regulatory authority submissions.
Maintain up-to-date knowledge of regulatory guidelines and standards.
Provide input on the development of clinical trial documents and templates.

Qualifications:

Advanced degree in life sciences, medicine, or a related field.
Experience in medical writing and regulatory submissions.
Strong understanding of regulatory requirements and clinical trial processes.
Excellent writing, editing, and communication skills.
Ability to work independently and manage multiple projects.

Medical Writer

Job Summary: A Medical Writer creates scientific documents and publications to communicate research findings and support medical and marketing objectives.

Key Responsibilities:

Write and edit manuscripts, abstracts, and posters for scientific conferences and journals.
Develop content for clinical study reports, protocols, and informed consent forms.
Collaborate with researchers, clinicians, and marketing teams.
Ensure accuracy and clarity of scientific content.
Stay current with scientific literature and advancements in relevant fields.
Adhere to publication guidelines and standards.

Qualifications: