Clinical Research Manager
2 months ago
This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, the Clinical Research Manager could be responsible for several countries in a cluster.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
**Responsibilities include, but are not limited to**:
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
- Escalates as needed different challenges and issues to Therapeutic Area Head/Clinical Research Director/Country Clinical Quality Manager and or Clinical Trial Team (as appropriate)
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
- Collaborates internally with HQ functions and locally with Pharmacovigilance, Regulatory and Global Medical Affairs to align on key decisions in his/her studies. Global Human Health to be consulted as needed.
- As a customer-facing role, this position will build business relationships and represent our Company with investigators.
- Shares protocol-specific information and best practices across countries\clusters.
**Qualifications, Skills & Experience**
**CORE Competency Expectations**:
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the Therapeutic Area Head or Clinical Research Director.
- Requires strong understanding of local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
**Behavioural Competency Expectations**:
- Strong leadership skills that enable and drive alignment with the goals, purpose and mission.
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.
- Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholde
We have other current jobs related to this field that you can find below
-
Clinical Research Manager
4 weeks ago
Midrand, South Africa MSD Full timeThis role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...
-
Associate Clinical Research Manager
1 week ago
Midrand, South Africa MSD Full timeWith support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...
-
Associate Clinical Research Manager
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeWith support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...
-
Clinical Research Associate
1 week ago
Midrand, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
5 days ago
Midrand, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally....
-
Clinical Research Associate
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeJob DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...
-
Clinical Research Associate
4 weeks ago
Midrand, Gauteng, South Africa MSD Full timeJob DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...
-
Clinical Research Associate
1 month ago
Midrand, South Africa MSD Full timeJob DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...
-
Sr. Clinical Research Associate
3 weeks ago
Midrand, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting...
-
Associate Clinical Research Associate
3 weeks ago
Midrand, South Africa MSD Full timeWith support of Senior Clinical Research Associate/Clinical Research Associate and/or CRA Manager, the Associate CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Primary Responsibilities: - Develops strong site relationships and ensures continuity of site...
-
Clinical Research Associate
2 weeks ago
Midrand, South Africa MSD Full time**Brief Description of Position** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, the organization's policies and procedures, quality standards and adverse event reporting...
-
Sr. Clinical Research Associate
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting...
-
Associate Clinical Research Associate
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeWith support of Senior Clinical Research Associate/Clinical Research Associate and/or CRA Manager, the Associate CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Primary Responsibilities: Develops strong site relationships and ensures continuity of site...
-
Clinical Research Associate Manager
3 weeks ago
Midrand, South Africa MSD Full timeThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to...
-
Sr. Clinical Research Associate
2 weeks ago
Midrand, South Africa MSD Full time**Brief Description of Position** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, organizational policies and procedures, quality standards and adverse event reporting...
-
Clinical Operations Manager
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. Clinical Operations Manager, Head COMs or...
-
Associate Clinical Research Associate
2 weeks ago
Midrand, South Africa MSD Full time**Brief Description of Position** With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical...
-
Country Clinical Quality Manager
2 weeks ago
Midrand, Gauteng, South Africa MSD Full timeOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.It is critical that, for all company-sponsored clinical trials, patient...
