Jemi Neil Consulting (JNC) is a human and business solutions company. We are a human resources consulting firm with a particular focus on executing various strategic initiatives so that our clients get the best out of their human resources.
We offer end-to-end HR solution services ranging from business consulting, HR structuring, HR management…
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Location: VI, Lagos
Summary of work
Our client, a multinational group of pathology laboratories, is looking to hire a project manager whose main responsibilities are to design and set up all documentation according to the test protocol. Manage and coordinate all received clinical trial samples, reports and accounts for designated clinical trials. Liaises with trial sponsors and resolves issues related to current clinical trial samples and sites.
- Manages and maintains strict confidentiality during clinical trials ensuring that a relationship of trust is established between BARC and the pharmaceutical company involved. Ensure that when new drugs are developed or tested, sensitive information about drug performance is not passed on to third parties.
- Records tests on the Collaborator system and completes NSF forms (New Setup Form) maintaining electronic records.
- Coordinates and facilitates the completion of the Technical Protocol (TP) following the relevant procedures.
- Attends initiation and set-up meetings prior to the start of clinical trials ensuring first-hand knowledge relating to the trial is acquired.
- Assists investigators, clinical trial research assistants, and trial personnel by ensuring that relevant laboratory aspects of clinical trial procedures are followed and adhered to as necessary.
- Issues stable reference ranges and DAIDS reference ranges for laboratory needs.
- Provides clients and corporate sponsor and site personnel with copies of laboratory certification, relevant CVs and contact details.
- Maintain, set up, design and update study workbooks for the duration of clinical trials ensuring record keeping and reference to the particular case study according to procedure and protocol.
- Captures all clinical trial information electronically on the collaboration system ensuring record keeping and audit trail.
- Generates an Investigator Instruction Manual containing all essential clinical trial documentation ensuring information is also electronically entered into the collaboration system for record keeping purposes.
- Generates a protocol-specific instruction (PSI) manual that informs the laboratory and receiving staff of protocol-specific laboratory requirements and tests.
- Assists the Information Technology (IT) Consultant in setting up all processes on the Meditech system ensuring that all relevant information is captured electronically for record keeping purposes. (eg, check-in procedures, demographics, results capture, report, fax, email and billing functions). Performs a full validation of the IT configuration.
- Follows up regularly with an investigator to ensure the clinical trial is running smoothly and if there are any discrepancies, immediate action can be taken to avoid trial/study violation.
- Checks the account on a monthly basis ensuring there are no instances of fraud/discrepancies
- Controls and verifies the statements generated for invoicing by ensuring the validity of the documentation.
- Performs day-to-day activities on the Meditech system as required for operational purposes e.g. Time & Attendance/Dr – finding patients
- Extract loads on Monday and ensure protocol and procedure are followed.
- Sends weekly charges to relevant customers ensuring efficient customer service, if necessary
- Performs random audit on application forms before scanning them into Oculus system ensuring record keeping and audit trail.
- Checks Data Clarification Forms (DCFs) daily and ensures that DCF forms are completed in a timely manner between the site and the relevant laboratory.
- Oversees day-to-day employee communication regarding faxes, kit orders, and study set-up ensuring efficient customer service.
- Study binder files and configuration are complete and available for audits
- Oversees and maintains obsolete files/incident records/shipping records and documents by maintaining records as requested or for investigation purposes.
- Regularly attends site meetings to ensure that good communication between the site and the laboratory concerned is carried out.
- Provides minutes of these meetings to senior management ensuring effective communication, record keeping and if discrepancies/issues are identified immediate action can be taken.
- Communicates solutions to staff as soon as issues are resolved ensuring effective communication between BARC staff and customers.
- Regularly monitors the LDMS (Laboratory Data Management System) ensuring materials management protocols are followed.
- Performs storage audits ensuring that no samples have been compromised.
- Sends a current storage log to the concerned laboratory informing them of the samples stored in the BARC storage. (if requested)
- Monthly reports and charges:
- Sends a monthly charge record to the relevant site/sponsor regarding clinical trial studies providing up-to-date information, if needed.
- Attends regular review meeting ensuring up-to-date records are printed and discussed regarding ongoing clinical trials.
- Writes incident reports and scans reports into Oculus ensuring up-to-date information is in the electronic record.
- Training: reads the protocol relating to the clinical trial, ensuring that the information is understood.
- Train all personnel involved in the clinical trial study ensuring the procedure and protocol are understood and sign off on training logs ensuring manual record keeping.
THE NECESSARY REQUIRED
- Must be familiar with and work on the following computer systems: Meditech, Collaborator, MS office (drafting of documents, trend analysis on Excel, training presentations) Internet/intranet
- Candidate must have 3-5 years of supervisory experience
- Diploma and relevant health certifications.
- English proficiency
- Consistency in achieving rigorous turnaround and performance targets in an environment characterized by high volumes,
- Unsociable working hours and shifts in some areas may be required
- Profitable use of all resources;
- Keep abreast of technical knowledge and changes at work;
- Effective functioning within a multidisciplinary team
- Able to prioritize urgent matters and manage stress.
- Ability to work in a team and positively influence colleagues.
- Ability to handle sensitive and confidential information
Interested and qualified candidates should send their CV to: [email protected] using the post as the email subject.
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