Remote Sdr Lead: Pipeline & Outreach Expert

Blacksmith Agency Llc

South Africa

Remote

ZAR 900,000 - 1,300,000

Full time

6 days ago
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Benefits offered by this job

Medical Aid Contribution
Gap Cover
Life Assurance
Provident Fund (8%)
13th Cheque

Job summary

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity. You will support global clinical research programs by delivering high-quality data management activities across Phase I-IV studies, ensuring data quality and regulatory compliance.

In this role you will collaborate with clinical teams, vendors, and study management to guarantee accurate data capture, review, reconciliation, and database management, contributing to study deliverables and

Qualifications

  • At least five years' experience in Data Management within pharma/biotech.
  • Understanding of Phase I-IV studies and data management with vendors.
  • Knowledge of ICH/FDA guidance, CDISC, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries.
  • Experience with Electronic Data Capture systems; RAVE preferred.
  • Strong communication, organization, and problem-solving skills.

Responsibilities

  • Lead data management activities for clinical studies with moderate guidance.
  • Coordinate data capture, edit checks, and data listings as required.
  • Oversee data management activities by CROs and vendors.
  • Develop annotated eCRFs and CRF completion guidelines with teams.
  • Support database design, testing, and issue resolution per standards.
  • Maintain study Data Management Plans and documentation.
  • Ensure inspection readiness and timely study deliverables.

Skills

Attention to detail
Analytical thinking
Organizational skills
Regulatory compliance
Communication skills

Education

Bachelor's Degree in a scientific or healthcare-related field

Tools

RAVE
Electronic Data Capture systems

Job description

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About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

We are seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity.
As a Senior Clinical Data Associate, you will support global clinical research programs by delivering high-quality data management activities across Phase I-IV clinical studies. This position plays a key role in clinical data quality, regulatory compliance, study execution, and cross-functional collaboration.
You will partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management activities. Responsibilities include supporting and leading data management activities, coordinating Electronic Data Capture (EDC) systems, developing study documentation, and contributing to database lock and study deliverables.
You will join a fast-paced, growth-oriented environment dedicated to a single sponsor and supporting important commercial and development programs worldwide. This role offers the opportunity to contribute directly to clinical research that advances new therapies while expanding your expertise across data management processes, clinical technologies, and cross-functional study operations.

Key Responsibilities
  • Lead a small clinical study or co-lead larger studies with moderate guidance.
  • Support multiple clinical studies while ensuring high standards of data quality and delivery.
  • Manage and monitor data management activities performed by CROs and external vendors.
  • Review study protocols and evaluate data capture requirements, including electronic Case Report Form (eCRF) design.
  • Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
  • Develop data edit check specifications and generate study data listings as required.
  • Coordinate the design, testing, and issue resolution of Electronic Data Capture systems in accordance with company standards.
  • Develop and maintain study Data Management Plans and supporting documentation
  • Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
  • Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
  • Maintain study workbooks and data management files while ensuring inspection readiness.
  • Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.
Candidate Profile

You'll thrive in this role if you bring:

  • Strong attention to detail, analytical thinking, and organizational skills.
  • Experience working within clinical research and regulated pharmaceutical or biotechnology environments.
  • The ability to collaborate effectively across multidisciplinary teams as well as with external partners and vendors.
  • A patient-focused mindset with a commitment to data quality and regulatory compliance.
  • Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms.
Required Qualifications
  • Bachelor's Degree in a scientific or healthcare-related field.
  • At least five years' experience in Data Management within the pharmaceutical or biotechnology industry.
  • Understanding of Phase I-IV clinical studies and demonstrated ability to perform core Data Management activities and work with vendors.
  • Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards.
  • Experience with Electronic Data Capture systems and clinical data management technologies. RAVE experience is strongly preferred.
  • Strong communication, organization, technical, and problem-solving skills.
Preferred Qualifications
  • Experience in Oncology or CNS therapeutic areas.
  • Experience supporting Phase III pivotal studies.
Benefits and Compensation
  • Medical Aid Contribution
  • Gap Cover
  • Life Assurance
  • Provident Fund (8%)
  • 13th Cheque

If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

As a Senior Marketing Manager at Thermo Fisher Scientific, you will contribute significantly to growth and innovation for the global leader in serving science. You'll develop and execute comprehensive marketing strategies to enhance our market position and enable customers to make the world healthier, cleaner, and safer. Managing a team of marketing professionals, you'll oversee multi-channel campaigns, digital initiatives, and strategic programs while collaborating across our organization to deliver compelling customer value propositions. You'll analyze market trends, optimize marketing performance, and support continuous improvement to advance our mission of enabling customer success.

REQUIREMENTS:

  • Advanced degree plus 6 years or bachelor's degree plus 8 years of proven marketing experience, with demonstrated success in B2B marketing strategy and execution
  • Preferred Fields of Study: Marketing, Business, Communications, Business Administration
  • Experience managing and developing marketing teams in a collaborative organization
  • Strong digital marketing expertise across channels including web, social media, email, and search
  • Excellent project management skills with ability to manage multiple initiatives simultaneously
  • Advanced analytical capabilities to measure campaign effectiveness and derive actionable insights
  • Strong written and verbal communication skills with ability to work effectively at all levels
  • Experience developing compelling content and customer value propositions
  • Demonstrated success in collaboration across functions and regions
  • Strong budget management and financial acumen
  • Proficiency with marketing automation platforms, CRM systems, and analytics tools
  • Ability to succeed in a dynamic environment while maintaining attention to detail
  • Healthcare/life sciences industry experience preferred
  • Travel required up to 20%

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.

What You'll Do:

  • Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
  • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
  • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
  • May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
  • May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
  • May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
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