Job Title: Project Manager
Location: VI, Lagos
Our client, a Multinational Pathological Group of Laboratories seeks to hire a project manager whose main responsibility is to design and set up all documentation as per trial protocol. Manage and coordinate all clinical trial samples received, reports, and accounts for designated clinical trials. Liaises with trial sponsors and resolves matters arising and relating to current clinical trial specimens and sites.
- Manages and maintains strict confidentiality during Clinical Trials ensuring that a trusting relationship is built between BARC and the relevant Drug Company. Ensuring that when new drugs are being developed or tested sensitive information regarding the performance of the drugs is not passed on to third parties.
- Registers trials onto the Collaborator system and completes NSF forms (New Setup Form) electronically ensuring record keeping.
- Coordinates and facilitates the completion of Technical Protocol (TP) adhering to relevant procedures.
- Attends initiation and set up meetings prior to clinical trials starting ensuring first-hand knowledge relating to the trial is gained.
- Assists Investigators, Clinical Trial Research Assistants, and trial staff ensuring relevant laboratory aspects of the Clinical Trial procedures are followed and adhered to If required.
- Issues stable reference ranges and DAIDS reference ranges for laboratory requirements.
- Supplies the clients and sponsor company and site personnel with copies of laboratory certification, relevant cvs, and contact details.
- Maintains, sets – up, designs and updates study binders for the duration of the clinical trials ensuring record keeping and a reference to the particular case study according to procedure and protocol.
- Captures all information pertaining to clinical trials electronically onto the Collaborator System ensuring record keeping and audit trail.
- Generates an investigator instruction manual containing all clinical trial essential documentation ensuring information is also captured electronically on the Collaborator System for record-keeping purposes.
- Generates a Protocol Specific Instruction manual (PSI) instructing the laboratory and receiving personnel on protocol-specific laboratory requirements and tests.
- Assists the Information Technologist consultant (IT) in setting up all processes on the Meditech system ensuring all relevant information is captured electronically for record-keeping purposes. (e.g. logging procedures, demographics, result in entry, reporting, faxing, email, and billing functions). Performs full validation of IT setup.
- Follows up regularly with an Investigator ensuring the Clinical Trial is running smoothly and should any discrepancies occur that immediate action can be taken to avoid trial/ study violation.
- Checks account on monthly basis ensuring no fraudulence occurrences/discrepancies
- Checks and verifies statements generated for billing ensuring the validity of the documentation.
- Performs daily activities on Meditech system as required for operational purposes e.g. Time and attendance / Dr – patient search
- Extracts out loads on Monday and ensures protocol and procedure are adhered to.
- Sends weekly out loads to the relevant clients ensuring effective customer service, If required
- Performs a random audit on requisition forms prior to scanning into the Oculus system ensuring record keeping and audit trail.
- Checks Data Clarification Forms (DCFs) on a daily bases and ensures completion of DCF forms within the required turnaround time between site and relevant laboratory.
- Oversees Collaborator communication daily relating to faxes, kit orders, and study set-up ensuring effective customer service.
- Study binder files and set–up are complete and available for audits
- Oversees and maintains obsolete files/incident files/shipping files and documents ensuring record-keeping if requested or for inquiry purposes.
- Attends site meetings regularly ensuring proper communication between the site and relevant laboratory is conducted.
- Forwards minutes of these meetings to senior management ensuring effective communication, record keeping, and if discrepancies/problems are identified that immediate action can be taken.
- Communicates solutions to staff as soon as problems are resolved ensuring effective communication between BARC staff and clients.
- Monitors the LDMS (Laboratory Data Management System) on a regular basis ensuring materials management protocols are adhered to.
- Performs audits on storage ensuring that no specimens have been compromised.
- Sends a current storage log to the relevant laboratory informing them of what samples are stored at BARC storage. (If requested)
- Monthly reports and out loads:
- Sends out monthly out load record to relevant site/sponsor relating to Clinical Trial studies providing up to date information, If required.
- Attends the regular review meeting ensuring up-to-date records are printed and discussed relating to current Clinical Trials.
- Writes incident reports and scans the reports into Oculus ensuring up-to-date information is on the electronic record.
- Training: Reads the protocol relating to the Clinical Trial ensuring information is understood.
- Trains all staff involved with the Clinical Trial study ensuring procedure and protocol are understood and signs off training logs ensuring manual record keeping.
- Must be familiar with and work on the following computer systems: Meditech, Collaborator, MS office (document writing, trends analysis on Excel, training presentations) Internet/ intranet
- Candidate must possess 3-5years supervisory experience
- Relevant Degree and certifications in Health.
- Proficiency in English
- Consistency in achieving stringent turnaround and performance targets in an environment that is characterized by high volumes,
- Unsociable working hours and shifts in some areas may be required
- Cost-effective utilization of all resources;
- Keeping abreast with technical knowledge and changes on the job;
- Effective functioning within a multi-disciplinary team
- Able to prioritize urgent matters and handle stress.
- Ability to work as part of a team and influence colleagues positively.
- Ability to handle sensitive and confidential information